news – page 6 – eisai china lnc.-爱游戏(ayx)中国官方网站

news – page 6 – eisai china lnc.-爱游戏(ayx)中国官方网站

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and nippon medac co., ltd. (headquarters: tokyo, ceo: hirohisa iriyama, “nippon medac”), a subsidiary of medac gesellschaft für klinische spezialpräparate mbh (headquarters: germany) announced today that they have obtained manufacturing and marketing approval from the japanese ministry of health, labour and welfare for the indication of the anti-rheumatic agent “metoject® subcutaneous injection 7.5mg syringe 0.15ml, 10mg syringe 0.20ml, 12.5mg syringe 0.25ml and 15mg syringe 0.30ml” (methotrexate, “mtx”) for the treatment of rheumatoid arthritis. metoject will be the first self-administrable mtx subcutaneous injection formulation for rheumatoid arthritis in japan. based on the license agreement signed by eisai and medac gmbh in may 2019, nippon medac will hold the marketing authorization of metoject, while eisai will be responsible for product distribution of metoject in japan.

the approval is based on the results of a phase iii clinical trial (mc-mtx.17/ra) conducted in japan by nippon medac to compare the efficacy and safety of metoject with that of oral mtx, which consisted of a double-blind phase and an extension phase. in the double-blind phase of this trial, 102 rheumatoid arthritis patients who had not been treated with mtx received either 7.5 mg/week of metoject or 8 mg/week of oral mtx for 12 weeks in repeated doses. the primary endpoint of acr20 response* at 12 weeks was 59.6% in the metoject group versus 51.0% in the oral mtx group, indicating comparable efficacy. the adverse drug reaction incidence rates in this trial were 25.0% in the metoject group and 34.0% in the oral mtx group. in the double-blind phase, the most common adverse drug reactions (incidence 5% and higher) were stomatitis (5.8%) in the metoject group, and nausea (12.0%) and stomatitis (6.0%) in the oral mtx group.

it is reported that there are approximately 700,000 – 800,000 rheumatoid arthritis patients in japan1. mtx is used as the first-line option for the treatment of rheumatic arthritis, but only the oral formulation is available in japan. eisai and nippon medac will provide a self-administrable subcutaneous injection as a new treatment option for rheumatoid arthritis patients in japan as soon as possible, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.

 

* acr20 is a criterion developed by the american college of rheumatology that measures improvement in clinical symptoms of rheumatoid arthritis. it expresses the percentage of patients who demonstrated a 20% or greater improvement in tender and swollen joint counts and at least three of the following five disease activity variables: patient assessment of pain; patient assessment of global disease activity; physician assessment of global disease activity; patient assessment of physical function; and chronic response protein or erythrocyte sedimentation rate concentrations.

 

 

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findings to be featured in a late-breaking proffered paper session at european society for medical oncology (esmo) congress 2022

 

tokyo and rahway, n.j., september 12, 2022 – eisai (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada) today announced the first presentation of results from the final analysis of the phase 3 leap-002 trial investigating lenvima®, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda®, the anti-pd-1 therapy from merck & co., inc., rahway, nj, usa versus lenvima monotherapy, as a first-line treatment for patients with unresectable hepatocellular carcinoma (uhcc). results are being presented during a proffered paper session at the european society for medical oncology (esmo) congress 2022, being held in paris, france and virtually from sept. 9-13 (abstract #lba34).

in the final analysis of the trial, there was a trend toward improvement for one of the study’s dual primary endpoints, overall survival (os), for patients treated with lenvima plus keytruda versus lenvima monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (hr=0.84 [95% ci: 0.71-1.00]; p=0.0227). the median os was 21.2 months (95% ci: 19.0-23.6) for lenvima plus keytruda and 19.0 months (95% ci: 17.2-21.7) for lenvima monotherapy. additionally, treatment with lenvima plus keytruda resulted in a trend toward improvement in the trial’s other dual primary endpoint of progression-free survival (pfs) versus lenvima monotherapy; however, the results did not meet the pre-specified threshold at the first interim analysis for statistical significance (hr=0.87 [95% ci: 0.73-1.02]; p=0.0466).

 

“the leap-002 trial reflects our research strategy to build on evolving standards of care to further improve outcomes for more people with unresectable hepatocellular carcinoma,” said dr. gregory lubiniecki, vice president, global clinical development, merck & co., inc., rahway, nj, usa research laboratories. “the median overall survival of 21.2 months seen with keytruda plus lenvima provides critical insights for further research into the potential role of this combination.”

“while the outcome is not what we had hoped, it is important for us to see that patients in the trial treated with lenvima monotherapy had a median overall survival of 19.0 months,” said corina dutcus, m.d., senior vice president, clinical research, oncology at eisai inc. “findings from the leap-002 trial will not only help advance our understanding and application of lenvima plus keytruda across our clinical development program but will also provide physicians with additional information on lenvima monotherapy’s use in unresectable hepatocellular carcinoma, where it is currently approved as a treatment option in multiple regions around the world, including the u.s., the european union (eu), japan and china.”

lenvima monotherapy is approved for the first-line treatment of patients with uhcc in the u.s., the eu and china and for patients with uhcc in japan. the approval of lenvima was based on results of the phase 3 reflect trial, which evaluated the efficacy and safety of lenvima versus sorafenib for the first-line treatment of patients with uhcc.

lenvima (marketed as kisplyx® for renal cell carcinoma [rcc] in the eu) plus keytruda is approved in the u.s., the eu and japan for the treatment of certain types of advanced endometrial carcinoma and advanced rcc. eisai and merck & co., inc., rahway, nj, usa are studying the lenvima plus keytruda combination through the leap (lenvatinib and pembrolizumab) clinical program in multiple tumor types, including but not limited to endometrial carcinoma, hcc, melanoma, non-small cell lung cancer, rcc, head and neck cancer, colorectal cancer, gastric cancer and esophageal cancer, across more than 15 clinical trials.

 

leap-002 study design and final analysis results (abstract #lba34)

leap-002 is a multicenter, randomized, double-blinded, active-controlled phase 3 trial (clinicaltrials.gov, ) evaluating lenvima plus keytruda versus lenvima monotherapy for the first-line treatment of adult patients with uhcc. patients were randomized 1:1 to receive lenvima (12 mg orally once daily [for patients with screening body weight of at least 60 kg] or 8 mg orally once daily [for patients with screening body weight less than 60 kg]) plus keytruda (200 mg intravenously [iv] on day 1 of each three-week cycle); or lenvima (12 mg orally once daily [for patients with screening body weight of at least 60 kg] or 8 mg orally once daily [for patients with screening body weight less than 60 kg]) plus saline placebo (iv administered on day 1 of each three-week cycle). lenvima was administered until progressive disease or unacceptable toxicity. keytruda/placebo was administered for up to 35 cycles (approximately two years).

the dual primary endpoints were pfs, as assessed by blinded independent central review (bicr) per response evaluation criteria in solid tumors version 1.1 (recist v1.1; recist v1.1 has been modified for this study to follow a maximum of 10 target lesions in total and a maximum of five target lesions per organ), and os. objective response rate (orr), as assessed by bicr per recist v1.1, was a key secondary endpoint. the trial was designed with two interim analyses and a final analysis for os. pre-specified efficacy boundaries were one-sided p=0.002 for pfs at interim analysis 1 and p=0.0185 for os at the final analysis.

as of the data cut-off for the final analysis (june 21, 2022), a total of 794 patients were enrolled and treated, with a median follow-up of 32.1 months (range, 25.8-41.1). a total of 534 os events had occurred, with 36 patients (9.1%) in the combination arm and 24 patients (6.1%) in the lenvima monotherapy arm remaining on study treatment.

the median os was 21.2 months (95% ci: 19.0-23.6) for lenvima plus keytruda versus 19.0 months (95% ci: 17.2-21.7) for lenvima monotherapy at the final analysis. the median pfs was 8.2 months (95% ci, 6.4-8.4) for lenvima plus keytruda versus 8.0 months (95% ci: 6.3-8.2) for lenvima monotherapy at the first interim analysis and 8.2 months (95% ci: 6.3-8.3) versus 8.1 months (95% ci: 6.3-8.3), respectively, at the final analysis. the orr was 26.1% (95% ci: 21.8-30.7) for lenvima plus keytruda versus 17.5% (95% ci: 13.9-21.6) for lenvima monotherapy at the final analysis. median duration of response was 16.6 months (range, 2.0 to 33.6 ) in the keytruda plus lenvima arm versus 10.4 months (range, 1.9 to 35.1 ) in the lenvima monotherapy arm at the final analysis.

the safety profile of lenvima plus keytruda was consistent with previously reported data on the combination. grade 3-4 treatment-related adverse events (traes) occurred in 61.5% of patients treated with lenvima plus keytruda versus 56.7% of patients treated with lenvima monotherapy. grade 5 traes occurred in 1.0% of patients treated with lenvima plus keytruda versus 0.8% of patients treated with lenvima monotherapy. in patients treated with lenvima plus keytruda, the five most common traes of any grade were hypertension (43.3%), diarrhea (40.3%), hypothyroidism (40.0%), palmar-plantar erythrodysesthesia (ppe) syndrome (33.2%) and proteinuria (30.6%). in patients treated with lenvima monotherapy, the five most common traes of any grade were hypertension (46.8%), hypothyroidism (35.7%), proteinuria (34.9%), diarrhea (33.9%) and ppe syndrome (30.6%). post-study systematic anti-cancer treatments were given for 44.1% of patients receiving lenvima plus keytruda versus 52.1% of those receiving lenvima monotherapy.

 

 

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analysis evaluates efficacy of eribulin in metastatic her2-low breast cancer across three clinical studies

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today results from a post hoc analysis of three randomized, pivotal, phase 3 studies (embrace trial/study 305, study 301 and study304) evaluating the efficacy of eribulin mesylate (marketed as halaven®) versus other chemotherapies (treatment of physician’s choice [tpc], capecitabine, and vinorelbine, respectively) in patients living with metastatic breast cancer (mbc) whose tumors have low or no her2 expression. these data were presented as a poster (presentation: #259p) at the european society for medical oncology (esmo) annual meeting (#esmo22), held virtually and in-person in paris, france from september 9-13, 2022.

the her2-low breast cancer subtype is a newly defined subset consisting of tumors that would have previously been considered her2-negative based on an immunohistochemistry (ihc) assay and an in situ hybridization (ish) assay. her2-low tumors express low amounts of the her2 protein, but not enough to be considered her2-positive. her2-low is defined as an ihc of 1 or 2 with a negative ish. of the approximate 288,000 new cases of female breast cancer expected to be diagnosed in the u.s. in 2022,1 it is estimated that approximately 80-85% of patients would previously have been considered to have the her2-negative subtype. of those patients, about 60% would now be considered to have the her2-low subtype.2

“in this post-hoc analysis, the outcomes seen in mbc patients whose tumors are considered her2-low are consistent with the results of the three pivotal phase 3 clinical trials,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “as the oncology community’s understanding of mbc continues to evolve, it’s important that we continue to evaluate the role of existing therapies in new contexts to contribute to the body of knowledge that is available to health care professionals.”

data from the post hoc analysis

the post hoc analysis included data from three trials — eribulin vs. tpc (, embrace trial/study 305), eribulin vs. capecitabine (, study 301), and eribulin vs. vinorelbine (, study 304) in patients with locally recurrent or mbc who had prior lines of chemotherapy treatments (≤2 for study 301; 2-5 for study 304 and embrace trial/study 305) including an anthracycline and a taxane. a total of 1,589 eligible patients were enrolled in the embrace trial/study 305, study 301 and study 304, and baseline characteristics were generally balanced between treatment arms in all studies.

median overall survival (os), median progression free survival (pfs) and objective response rate (orr) were analyzed. pfs and orr were measured per response evaluation criteria in solid tumors version (recist) (v1.0 for embrace trial/study 305 and study 301; v1.1 for study 304) by independent imaging review. orr was measured in evaluable patients (embrace trial/study 305) and in the intent-to-treat population (study 301 and study 304).

in the post hoc analysis, os, pfs, and orr among patients with her2-low or her2-negative status were generally similar to those of the eribulin treatment arms overall in each of the embrace trial/study 305, study 301 and study 304.3,4,5 efficacy results for patients with her2-low and her2-negative status across all three studies are summarized in the table below:

 

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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has filed a supplementary new drug application in japan for its in-house discovered antiepileptic drug (aed) fycompa® (perampanel) seeking approval for an injection formulation as a new route of administration.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. the agent is a highly selective, noncompetitive ampa receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. two oral formulations of fycompa are available in japan: a tablet and a fine granule formulation. due to concern about the risks associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment other than via oral administration. the injection formulation was developed as a non-oral administration route to meet such medical needs, and its bioequivalence to the tablet formulation, as well as the confirmation of the safety and tolerability of the injection formulation when administered as an alternative therapy to the tablet, lead to this application. the addition of an injection formulation of fycompa, the only ampa receptor antagonist-based aed, to the product lineup is expected to provide a new treatment option for a broader range of patients.

it is estimated that there are approximately 1 million patients with epilepsy in japan, and although onset occurs at any age, it is most common in people aged 18 and younger, and the elderly.

eisai considers neurology, including epilepsy, a therapeutic area of focus and is in continued pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

 

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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its u.s. subsidiary eisai inc. has entered into a memorandum of understanding with c2n diagnostics (“c2n”) that will seek to build awareness about how blood-based assays in the diagnosis for people living with cognitive impairment, including alzheimer’s disease (ad), may help patients receive a timely diagnosis and appropriate treatment. collaborating with c2n, eisai inc. will work to build awareness and develop real-world evidence to support the use of blood-based assays in people living with cognitive impairment in clinical practice outside of clinical trial settings in the u.s. blood-based assays could result in the development of new standards in clinical care that may enable timely and accurate diagnoses for people living with cognitive impairment.

the number of people with dementia is growing substantially; more than 55 million people worldwide are living with dementia, and this number is expected to increase to 78 million by 2030.1 accurate diagnosis remains a barrier to early and proper care management; research reviews estimate that between 40 and 60 percent of adults with probable dementia are undiagnosed.2 importantly, blood-based assays may be able to help identify which patients may benefit from therapy, and therefore may help streamline care and reduce healthcare spending. early detection, diagnosis and treatment of dementia protects individuals against risks from delayed or missed diagnosis and allows individuals, their families and their caregivers to plan for the future as the condition progresses.2

the development and adoption of blood-based assays as simple diagnostic tools, in every day clinical practice is an important step in improving care for people in remote and underserved communities where access to the traditional diagnostic tools of positron emission tomography (pet) and lumbar punctures are not a viable option.

in collaboration with various partners, eisai will engage in practical application of simple and less invasive diagnostic technologies and diagnostics for dementia, including blood tests, and will work to improve the medical environment in which people with dementia can receive appropriate treatment, thereby contributing to relieving anxieties of people living with dementia and their families around the world.

 

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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and lifenet insurance company (headquarters: tokyo, president: ryosuke mori, “lifenet”) announced today that they have entered into a capital and business alliance agreement to collaborate in dementia and other areas, with the aim of helping reduce the burden of medical and nursing care for people living in japan’s aging society.

new insurance products and services will be developed by mutually leveraging eisai’s wealth of experience and network in drug discovery and disease awareness activities in the field of dementia, which it has built up over many years, and lifenet’s know-how and technologies cultivated in insurance products and related services. furthermore, eisai and lifenet will promote the creation of healthcare solutions utilizing various data and customer touchpoint owned by both companies, and expand the ecosystem that contributes to solving social issues.

under the terms of the agreement, eisai will obtain lifenet common stock worth 300 million yen through market transaction.

under the medium-term business plan“eway future & beyond”, which began in april 2021, eisai is expanding its main role in healthcare, that is, we should contribute not only to people in the medical domain but also to people in the daily living domain. eisai aim’s to evolve into a company that empowers them “to realize their fullest life” by creating solutions based on science and data in the fields with high unmet medical needs where eisai has the greatest strength, through an ecosystem developed in collaboration with other industries. this alliance will accelerate the building of a dementia ecosystem that contributes through prevention, treatment, and aftercare in a comprehensive manner.

lifenet has worked with other industry partners to provide products and services that meet the needs of the times. through this alliance, as stated in , lifenet will continue providing health and wellness tips beyond the framework of life insurance to create value in our policyholders’ lives, while creating a precedent for future generations as to what life insurance is (and should be) all about.

eisai and lifenet will contribute to solving social issues through the creation of an ecosystem while pursuing the possibility of collaborations with other companies and organizations that support the objectives of the two companies’ activities.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been included in the ftse4good index series for the 21st consecutive year since its initial inclusion in 2002. the ftse4good index series is a global index series for socially responsible investment.

the ftse4good index series was developed by ftse russell to promote investment in companies that meet global environmental, social and governance (esg) standards. eisai received particularly high scores in “corporate governance”, “customer responsibility”, “labor standards” and “tax transparency”, among others. as of the end of june 2022, 1,092 companies worldwide and 224 japanese companies were included in the ftse4good developed index series.

currently, in addition to the msci esg leaders indexes, another global esg investment index, eisai is also listed in the ftse blossom japan index, the ftse blossom japan sector relative index, the msci japan esg select leaders index, the msci japan empowering women index (win) and the s&p/jpx carbon efficient index, which are esg investment indices for japanese stocks adopted by the government pension investment fund (gpif).

eisai’s corporate concept is to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides to them, as well as address diverse healthcare needs worldwide. by strengthening its esg initiatives and increasing non-financial value, eisai is striving to sustainably enhance corporate value based on this concept.

for more information on our esg initiatives, please visit .

 

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eisai co. ltd (headquarters: toyoko, ceo: haruo naito, “eisai”) announced today that the company will present research from its alzheimer’s disease (ad) pipeline, including new data for lecanemab (ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody for the treatment of mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed presence of amyloid pathology in the brain, at the (aaic) to be held in san diego, ca and virtually from july 31 to august 4, 2022. eisai will present data and research in three oral and 18 poster presentations at the meeting.

on july 5, 2022 (u.s), eisai announced that the u.s. food and drug administration (fda) accepted the biologics license application (bla) for lecanemab under the accelerated approval pathway and was granted priority review, with a prescription drug user fee act (pdufa) action date of january 6, 2023. the readout of the primary endpoint data of clarity ad will occur in the fall of 2022. the fda has agreed that the results of clarity ad when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.

key eisai aaic presentations

· effect of genotype on aria-e incidence by lecanemab: results from a modeling simulation to evaluate the effect of apoe4 genotype on aria-e incidence from study 201 core and comparison to the observed incidence in the open-label extension among those newly treated with lecanemab. (virtual developing topics #69402)

· lecanemab subcutaneous dosing:

* results from a study in healthy subjects to evaluate the absolute bioavailability, pharmacokinetics, safety, and immunogenicity of lecanemab following a single fixed 700 mg subcutaneous dose. (poster/abstract #69438)

* modeling and simulation analysis aimed at showing the equivalence of fixed weekly subcutaneous dose of lecanemab to body weight-based 10mg/kg biweekly intravenous dose. (poster/abstract #69429)

· ethnic and racial diversity in eisai clinical trials: an evaluation of us enrollment across lecanemab (study 201 and clarity ad) and elenbecestat missionad studies in early ad to assess racial and ethnic groups and the impact of eligibility criteria in the united states. (poster/abstract  # 69198)

· β-amyloid assays predict brain β-amyloid pathology: data from the eisai and sysmex collaboration reporting on the fully automated plasma aβ40 and aβ42 immunoassays and their performance for predicting brain aβ pathology defined by amyloid pet. (poster/abstract # 68727)

· comprehensive csf tau profiling from dominantly inherited alzheimer network (dian): an oral presentation that shares results from a study in patients enrolled in washington university school of medicine’s dian-observational cohort that used eisai’s anti-microtubule binding region (mtbr) antibody, e2814, to profile mtbr-tau and then assessed timing to mtbr-tau changes in csf and correlation to clinical, cognitive, and biomarker changes. (oral presentation # 65313)

 

“the lecanemab data eisai will present at aaic 2022 continues to build the body of knowledge about our investigational anti-amyloid beta protofibril antibody as we work toward the phase 3 confirmatory clarity ad readout this fall,” said michael irizarry, m.d., senior vice president, deputy chief clinical officer, alzheimer’s disease and brain health, eisai inc. “additional research presented will highlight eisai’s efforts to improve ethnic and racial diversity in our early alzheimer’s disease clinical trials in the united states so that study populations mirror the u.s. medicare population, as well as research from our collaboration with sysmex on potential biomarkers that may contribute to early diagnosis of alzheimer’s disease.”

 

aaic 2022 presentations relating to eisai’s key compounds and research

 eisai oral presentations

 

this release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

 

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libby holman

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second publication on the potential value of lecanemab in patients with early alzheimer’s disease using simulation modeling

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (aβ) protofibril antibody lecanemab in people living with early alzheimer’s disease (ad) using a validated disease simulation model, ad archimedes condition event (ad ace) model1,2,3 from the healthcare payer and societal perspectives in the united states, in the peer-reviewed journal neurology and therapy. this is the second publication of lecanemab’s potential value. it follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in neurology and therapy in april 2022.4 while the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). as reported in the previous publication, it was suggested that compared to standard of care* (soc), individuals treated with lecanemab in addition to soc (lecanemab soc) may potentially experience slower disease progression to mild, moderate and severe ad from baseline by 2.51, 3.13 and 2.34 years on average, respectively. the preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (qaly**) and reduction in the formal and informal care costs***. additionally, the ad ace model framework used in this study allowed assessment of the potential value of lecanemab in different scenarios and sensitivity analyses, including the impact of patient subsets, alternative treatment stopping rules**** and potential dosing regimens as well as major sources of uncertainty.

 

eisai is committed to conducting and sharing these types of clinical and socioeconomic analyses to establish trust as we work to potentially bring lecanemab to people living with early ad who have confirmed presence of amyloid pathology in the brain. to that end, eisai would like to provide a common foundation for stakeholders’ discourse regarding the potential clinical and socioeconomic value of lecanemab from the societal perspective, not to assign a price for lecanemab at this time.

 

this model-based simulation was conducted using the results of a phase 2b clinical trial (study 201) evaluating the efficacy and safety of lecanemab for early ad with confirmed amyloid pathology as well as published literature. it also estimated the potential economic value of lecanemab soc over a broad range of willingness-to-pay thresholds from $50,000 to $200,000 per qaly gained as recommended by the institute for clinical and economic review (icer)*****. lecanemab soc was predicted to result in a gain of 0.61 qalys and a decrease in total non-treatment costs of $8,707 per person from the healthcare payer perspective (societal perspective: 0.64 qalys gain and $11,214 decrease) compared to the soc for patients with early ad who have confirmed presence of amyloid pathology. the potential annual value-based price (vbp) of lecanemab was estimated at $9,249 to $35,605 (societal perspective: $10,400 to $38,053) based on this early economic assessment.

 

icer’s value framework5 indicates that value cannot be wholly derived from measures of clinical and cost-effectiveness, so contextual considerations and an examination of other benefits and disadvantages are also added into the framework when assessing long-term value. this may lead to using the societal perspective and higher end of the broad range of willingness-to-pay threshold in estimating the justifiable price of lecanemab, given the large societal burden of ad relative to direct healthcare costs.

 

many people living with ad received informal care from their family and friends totaling more than 16 billion hours of unpaid care valued at $271.6 billion in the u.s. in 2021.6 these predicted and simulated findings suggest that early treatment with lecanemab may reduce these costs and economic burdens, and provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. the phase 3 lecanemab clarity ad data will soon be available to inform the model inputs and refine the findings. in the event that lecanemab receives the u.s. food and drug administration’s (fda) approval, eisai may determine a vbp using this framework along with other considerations, such as affordability, health system sustainability, etc.

 

“eisai’s goal is to create therapies, such as our investigational anti-amyloid beta protofibril antibody lecanemab, that may help impact the anxieties of people living with alzheimer’s disease and their families. for alzheimer’s disease, it is important to evaluate the holistic value of therapies taking into account not only medical costs but also the immense societal costs,” said ivan cheung, senior vice president, president neurology business group and global alzheimer’s disease officer, eisai co., ltd., chairman and ceo, eisai inc. “as part of eisai’s commitment to our human health care mission, trust and transparency, we will continue to publish data and information about lecanemab and look forward to sharing the results of the lecanemab confirmatory phase 3 clarity ad clinical trial this fall.”

 

eisai completed lecanemab’s rolling submission of a biologics license application (bla) for the treatment of early ad to the fda under the accelerated approval pathway in may 2022. the clarity ad phase 3 clinical study for lecanemab in early ad is ongoing and completed enrollment in march 2021 with 1,795 patients. the readout of the primary endpoint data of clarity ad will occur in the fall of 2022. the fda has agreed that the results of clarity ad, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. dependent upon the results of the clarity ad clinical trial, eisai may submit for full approval of lecanemab to the fda during eisai’s fiscal year 2022, which ends in march2023. in japan, in march 2022, eisai initiated submission of application data to the pharmaceuticals and medical devices agency (pmda) under the prior assessment consultation system with the goal of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of clarity ad during eisai’s fiscal year 2022. also, in europe, based on the results of the clarity ad study, eisai plans to submit a new drug application in fiscal year 2022.

 

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

 

*  standard of care (soc) for ad currently consists of lifestyle modifications and pharmacologic treatment of symptoms.

** the quality-adjusted life year (qaly) is a measure of the value of health outcomes. since health is a function of length of life (i.e., quantity) and quality of life (qol), the qaly was developed as an attempt to combine the value of these attributes into a single index number. one qaly equates to one year in perfect health. qaly scores range from 1 (full health) to 0 (dead). for example, a new intervention may increase length of life by 3 years and improve quality of life by 70% (qaly score of 2.1) compared to an existing intervention that may increase length of life by 3 years and only improve qol by 50% (qaly score of 1.5), the incremental qaly for this new intervention will be 0.6 qalys.

*** formal and informal care costs do not include lecanemab drug cost.

**** alternative treatment stopping rules were explored in scenario analyses where treatment with lecanemab was stopped after a fixed duration of 1.5, 3 and 5 years.

***** icer is a non-profit research organization in the u.s. that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations.

 

1 kansal ar, tafazzoli a, ishak kj, krotneva s. alzheimer’s disease archimedes condition-event simulator: development and validation. alzheimers dement (ny). 2018;4:76-88. published 2018 feb 16. doi:10.1016/j.trci.2018.01.001.

2 tafazzoli and kansal. disease simulation in drug development, external validation confirms benefit in decision making. the evidence forum. 2018.

3 tafazzoli a, weng j, sutton k, et al. validating simulated cognition trajectories based on adni against 436 trajectories from the national alzheimer’s coordinating center (nacc) dataset. 11th edition of clinical trials on 437 alzheimer’s disease (ctad); barcelona, spain: 2018.

4 tahami monfared aa, tafazzoli a, ye w, chavan a, zhang q. long-term health outcomes of lecanemab in patients with early alzheimer’s disease using simulation modeling. neurol ther 11, 863–880 (2022). https://link.springer.com/article/10.1007/s40120-022-00350-y.

5 icer value framework 2020-2023. 2022.

6 alzheimer’s association. 2022 alzheimer’s disease facts and figures 2022 available from:

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

eisai inc. us

libby holman

201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that eisai has acquired a majority of the shares issued by arteryex inc. (headquarters: tokyo, ceo: li dongying, “arteryex”), a company that plans and develops software related to digital solutions such as provision of medical information platforms, through purchase of shares and subscription of a third-party allocation of common shares, and made it a subsidiary, as of march 31, 2022. the two companies will work together to develop and provide phr (personal health record)-related services for patients, healthcare professionals and society at large.

 

eisai launched its medium-term business plan “eway future & beyond” in april 2021, where the perspective to be shifted from that of patients to the people or each consumer. with “empowering the people to realize their fullest life” as the vision, eisai delivers not only pharmaceutical products but also solutions to the people, by utilizing the latest digital technology such as ai, and aims to remove the anxiety of the people.

arteryex has excellent software development capabilities and has developed its own phr-related product services, including apps for storing and converting health-related information of patients undergoing treatment and a wide range of users into data, as well as apps for companies for employee health management.

 

eisai aims to strengthen and rapidly expand its digital solution business base by acquiring arteryex’s development capabilities and quality phr products through the subsidiary acquisition. in addition to reaching a new customer segment of existing products, eisai will promote developing products including new applications by utilizing arteryex’s input technology and systems used in image data. furthermore, eisai will advance the utilization of data acquired through phr-related products, as the entire eisai group, leveraging the data management know-how that eisai has practiced in its medicine creation activities and disease awareness activities.

for building the eisai universal platform (eup), through those initiatives, eisai will enhance creating a packaged solution, as well as strengthen its delivery infrastructure, for maintenance and improvement of health, prevention and disease awareness, and will expand its contribution to the people.

 

the current management team of arteryex will remain after the conversion to a subsidiary. the acquisition by eisai of arteryex as a subsidiary will not have a material impact on the consolidated financial results of arteryex.

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

 

[notes to editors]

1. about arteryex inc.

arteryex is a software planning and development company specializing in systems and application software in the medical and healthcare fields. in the era of 100 years of life, it is becoming increasingly important for people to stay healthy. on the other hand, the data needed to advance medical care is fragmented and dispersed in various fields. the company’s goal is to better understand the needs of each individual and to achieve optimal health care and medical treatment for each person with combining the latest technologies, such as blockchain and ai, to maximize the use of data that is currently underutilized.

outline of arteryex

 

company name: arteryex inc.
location: 1-4-4, iwamoto-cyo, chiyoda-ku, tokyo, japan
representative: li dongying
principal businesses: software planning and development
capital: 32 million yen
foundation: march, 2018
number of employees: 19

 

for more information about arteryex, please visit

2. about phr products owned by arteryex

■  click-karte

“click-karte” is a smartphone application for general consumers that automatically converts information, such as the items listed in the medication handbook and the results of blood tests and/or medical examinations, into data by photographing them with a smartphone and uploading to the system. after launching in november 2020, the app has had more than 20,000 downloads at this point. this may contribute to simplification of data input in apps to be developed by eisai in the future.

 

■  with leaf

“with leaf” is a smartphone application developed for companies to manage employee health internally with the goal of promoting employee health and improving company productivity. the app is designed not only to contribute to promoting employees’ habitual exercise with application-based activities that encourage employees to practice exercise by setting the number of steps and walking distance, but also to raise awareness of employees for their health and exercise status by recording the number of steps taken, distance walked, and calories burned on a daily basis. it also has a chat function for individuals and groups, which can be used to stimulate communication among employees.

 

■  sasaeru note

“sasaeru note” is a system that links a smartphone application for patients with a viewing system exclusively for healthcare professionals, enabling medical personnel to capture the health status reported by patients while in the home environment. it allows patients and their families to review records of the occurrence of adverse reactions to medications, as well as enables to prevent patients and their families from unintentionally forget to report about a patient’s daily records and health status when they share the information with healthcare professionals.

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