news – page 4 – eisai china lnc.-爱游戏(ayx)中国官方网站

news – page 4 – eisai china lnc.-爱游戏(ayx)中国官方网站

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of two abstracts at the society of gynecologic oncology (sgo) 2023 annual meeting on women’s cancer (#sgomtg), which is taking place in-person in tampa, florida and virtually from march 25-28.

 

notable research to be featured in the scientific plenary ix: the best of the rest session includes a presentation of real-world outcomes and healthcare resource utilization in patients with recurrent or advanced endometrial carcinoma who were rechallenged with platinum chemotherapy in europe (abstract: #17). also to be presented are data from the leap (lenvatinib and pembrolizumab) clinical program analyzing tumor-response from the lenvatinib (lenvima®) plus pembrolizumab (keytruda®) arm of the pivotal phase 3 study 309/keynote-775 trial in patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting (; abstract: #518).

 

“we look forward to sharing our data at this year’s sgo annual meeting, particularly a new study that will be presented in an oral scientific plenary session featuring real-world outcomes in patients with recurrent or advanced endometrial cancer who were rechallenged with platinum chemotherapy,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “we believe this research is important to the healthcare providers and patients we aim to serve because it is essential to understand treatment dynamics and related outcomes in clinical practice. as a human health care company, we remain steadfast in our commitment to advance the science of cancer medicine through the generation of real-world evidence.”

 

in march 2018, eisai and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with merck’s anti-pd-1 therapy pembrolizumab. to date, more than 10 trials have been initiated under the leap clinical program, which is evaluating the combination across multiple tumor types.

 

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

 

the full list of eisai presentations is included below. full abstracts will be posted the day of scheduled presentations.

 

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

presentations explore aria with the use of antiplatelets or anticoagulants and isolated aria-h in patients from eisai’s lecanemab phase 3 confirmatory clarity ad study in early alzheimer’s disease

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the company will present the latest findings on lecanemab (generic name, u.s. brand name: leqembi™), eisai’s anti-amyloid beta (aβ) protofibril* antibody for the treatment of alzheimer’s disease (ad), at the 2023 international conference on alzheimer’s and parkinson’s diseases and related neurological disorders (ad/pd™) from march 28-april 1 in gothenburg, sweden and virtually. eisai will present new findings from the company’s large, global phase iii confirmatory study of lecanemab, clarity ad, including research into the management and monitoring of amyloid-related imaging abnormalities (aria) and health-related quality of life (hrqol) measures. eisai will also host a symposium, titled “patient clinical care pathway in alzheimer’s disease: dialogue amongst experts,” which will address the evolving landscape in ad. the lecanemab data and additional research findings from eisai’s ad portfolio will be featured in 11 presentations, including seven oral and four poster presentations.

 

“our latest research examines the real-world outcomes based on lecanemab’s impact on clinical results and safety, including its effect on health-related quality of life. through our ongoing research, we hope to help simplify the patient journey and improve the lives of those living with alzheimer’s disease,” said michael irizarry, m.d., deputy chief clinical officer and senior vice president of clinical research at eisai inc. “in addition to lecanemab, eisai is presenting on several other key issues that will shape the future of alzheimer’s disease and brain health, including the next generation of clinical care and diagnostic pathways, exploration of unique populations affected by the disease, and accelerating drug development. we look forward to sharing our latest findings, including new insights from eisai’s clarity ad trial of lecanemab, with the scientific community at ad/pd 2023.”

 

key eisai lecanemab and ad presentations

  • two presentations related to aria in the clarity ad trial will be presented during an oral session on thursday, march 30:
    – an analysis evaluating the use of antiplatelet and anticoagulant drugs in patients who experienced aria.
    – an analysis of isolated aria-h events in the clarity ad trial.
  • research evaluating caregiver burden and hrqol across multiple scales using clarity ad data will be presented during an oral session on thursday, march 30.
  • research studying the characterization of aβ protofibrils and the unique binding properties and mechanisms of aβ clearance of lecanemab on friday, march 31.
  • designing the next generation clinical care and diagnostic pathway for alzheimer’s disease: a presentation focused on a new pathway which interweaves clinical, biological and digital assessments to guide an individualized ad patient journey on friday, march 31.

eisai symposium – patient clinical care pathway in ad: dialogue amongst experts

eisai is sponsoring a symposium featuring three prominent clinical experts in the field of ad, dr. alireza atri, dr. sharon cohen and dr. lutz frölich, who will provide insights on the ad landscape, evolving diagnostic workflow, identifying appropriate patients, and addressing patient needs on wednesday, march 29. the session aims to provide guidance on the clinical management of patients and drive effective communication between physicians and patients.

 

 

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

* protofibrils are large aβ aggregated soluble species of 75-5000 kd.1

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

eisai europe, ltd.

(europe, australia, new zealand and russia)

emea communications department

44 (0) 786 601 1272

 

eisai, inc. (u.s.)

libby holman

1-201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it was selected as the winner of the “basic achievement grand prize” at the “2023 j-win diversity award” held by non-profit organization japan women’s innovative network (npo j-win).

 

the “j-win diversity award” has been held annually since 2008 with the aim of accelerating the promotion of diversity and inclusion (d&i) in japanese companies by awarding leading businesses that are promoting d&i. among the company prizes, eisai was selected as the winner of the “basic achievement grand prize”, which is the highest award within the “basic category” covering businesses who demonstrate the significance and purpose of female empowerment, developing systems and frameworks with set goals, and are taking action as a first step towards d&i promotion.

reasons for award-winner selection

promoting d&i by viewing acquisition of diverse human talents and their successes as essential for realizing their corporate concept. while promoting company-wide initatives with the “de&i (diversity, equity & inclusion) promotion committee”, encouraging independent activities appropriate to onsite challenges through “de&i projects” at each department. further expansion in the number of female managers is expected down the road.

 

highly regarded measures/initiatives

1) top management commitment and promotional framework for d&i

・promoting d&i by regarding acquisition and retention of diverse human talents and their successes as essential to evolve the “hhc (human health care)” concept and realize an “hhceco company”

・promoting activities by division, setting up “de&i projects” for global functions, such as corporate, r&d and manufacturing operations as well as each regional function, in parallel with implementing the ”de&i promotion committee” throughout the company.

・plans to introduce a new personnel assessment system from fy 2023, which utilizes a behavioral assessment item “diversity & synergy” to further focus on diversity.

 

2) developing female leaders

・implementing e-win (eisai women’s innovative network) program to encourage personal growth and foster career awareness/aspirations

 

3) reforming corporate culture/promoting increased awareness

・promoting dialogues within the organization by leveraging monthly engagement survey

 

eisai’s corporate concept (also known as the hhc concept) is to give first thought to patients and the people in the daily living domain, and increase the benefits that healthcare provides to them as well as meet their diversified healthcare needs worldwide. eisai aims to realize the spiral of knowledge generated by diversity, regardless of differences in nationality, gender, age, etc., leading to the creation of innovation. eisai also acquired third party appraisals including “platinum kurumin”, an accreditation for organizations implementing high level parenting support by ministry of health, labour and welfare, as well as “the new diversity management selection 100” and “health & productivity management outstanding organizations” by ministry of economy, trade and industry.

 

eisai is promoting de&i throughout the company to ensure it has the diversity to meet increasingly diverse needs of patients and the people in the daily living domain.

for more information about eisai’s de&i promotion, please visit it’s .

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been certified as a health and productivity management outstanding organization in the large enterprise category (white 500) by japan’s ministry of economy, trade and industry and the nippon kenko kaigi.

under the certified health and productivity management outstanding organization recognition program, the nippon kenko kaigi examines large enterprises, small and medium enterprises and other organizations engaging in initiatives for overcoming health-related challenges in regional communities or for promoting health-conscious activities led by the nippon kenko kaigi. it recognizes outstanding enterprises engaging in efforts for health and productivity management by evaluating from a business-management perspective based on the following criteria: “management philosophy and policies”, “organized frameworks”, “systems and implementation of measures”, and “evaluation and improvement”. eisai exceeded the average of its industry peers in all criteria, receiving particularly high scores for items such as “well adopted by employees” (in the criteria of organized frameworks), “lifestyle improvement” and “other measures*” (in the criteria of systems and implementation of measures). the program was launched in 2017, and this is the fifth time that eisai was certified as a “white 500” company.

eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. eisai calls this the “human health care (hhc)” concept. eisai regards its employees as an important stakeholder and asset for the realization of its hhc concept. eisai believes that its commitment to maintaining and improving the health of human resources is fundamental to develop highly engaged employees who are motivated to contribute voluntarily toward the realization of the hhc concept. eisai issued the “eisai health declaration” in 2019, and has strategically implemented health management for employees from a management perspective.

eisai will continue to promote health and productivity management to increase non-financial value and further contribute to increasing the benefits of patients and the people in the daily living domain.

* measures to address health issues specific to women and the elderly, long working hours, mental health, dependents of the company’s employees, and prevention of infectious disease during covid-19 pandemic.

 

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

confirmatory phase 3 clarity ad data to be evaluated by fda in determining whether to convert accelerated approval of leqembi to a traditional approval

priority review accelerates fda review time with a prescription drug user fee act (pdufa) target action on july 6, 2023

 

tokyo and cambridge, mass., march 6, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the u.s. food and drug administration (fda) has accepted eisai’s supplemental biologics license application (sbla) for leqembi™ (lecanemab-irmb) 100 mg/ml injection for intravenous use, supporting the conversion of the accelerated approval of leqembi to a traditional approval. the leqembi application has been granted priority review, with a prescription drug user fee act (pdufa) action date of july 6, 2023. the fda is currently planning to hold an advisory committee to discuss this application but has not yet publicly announced the date of the meeting.

leqembi is a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (aβ), approved under the accelerated approval pathway for the treatment of alzheimer’s disease (ad) on january 6, 2023. treatment with leqembi should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of aβ pathology. on the same day that leqembi received its accelerated approval, eisai submitted the sbla to the fda for approval under the traditional pathway.

the sbla is based on the findings from eisai’s recently published large, global confirmatory phase 3 clinical trial, clarity ad. leqembi met the primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, results of the clarity ad study were presented at the clinical trials on alzheimer’s disease (ctad) conference and simultaneously published in the peer-reviewed medical journal, the new england journal of medicine.

leqembi was approved under accelerated approval in the u.s. and  was launched in the u.s. on january 18, 2023. the accelerated approval was based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad, and its continued approval may be contingent upon verification of leqembi’s clinical benefit in a confirmatory trial. the fda has determined that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab.

eisai serves as the lead of leqembi development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

contacts
eisai

media contact:

eisai co., ltd.

public relations department

tel: 81 (0)3-3817-5120

 

eisai inc. (u.s.)

libby holman

1-201-753-1945

 

eisai europe, ltd.

(uk, europe, australia, new zealand and russia)

emea communications department

44 (0) 786 601 1272

 

investor contact:

eisai co., ltd.

investor relations department

tel: 81 (0) 3-3817-5122

biogen inc.

 

media contact:

natacha gassenbach

1-857-777-6573

 

 

investor contact:

mike hencke

1-781-464-2442

 

tokyo and cambridge, mass., february 28, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the biologics license application (bla) for lecanemab (brand name in the u.s.: leqembi™), an investigational anti-amyloid beta (aβ) protofibril antibody, has been designated for priority review by the national medical products administration (nmpa) in china. the priority review and approval procedure was implemented by the nmpa with the aim of accelerating research, development and launch of new medicines that have significant clinical value. under this procedure, the assessment period is expected to be shortened.

in china, eisai initiated submission of data for the bla to the nmpa in december 2022. eisai initially submitted a package that includes data from the phase ii clinical trial (study 201) and the top-line data of the large global phase iii clarity ad study in mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed aβ accumulation in the brain. eisai will submit additional data including full data of the clarity ad study, as directed by the nmpa.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at the 2022 clinical trials on alzheimer’s disease (ctad) conference, and simultaneously published in the new england journal of medicine, a peer-reviewed medical journal.

in the u.s., lecanemab was granted accelerated approval by the u.s. food and drug administration (fda) on january 6, 2023. on the same day, eisai submitted a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway. in europe, eisai submitted a marketing authorization application (maa) to the european medicines agency (ema) on january 9, 2023,  which was accepted on january 26, 2023. in japan, eisai submitted a marketing authorization application to the pharmaceuticals and medical devices agency (pmda) on january 16, 2023, and  priority review was designated by the ministry of health, labour and welfare (mhlw)  on january 26, 2023.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

contacts
media contact:

eisai co., ltd.

public relations department

tel: 81-(0)3-3817-5120

 

 

investor contact:

eisai co., ltd.

investor relations department

tel: 81-(0)3-3817-5122

media contact:

biogen inc.

natacha gassenbach

1-857-777-6573

public.affairs@biogen.com

 

investor contact:

biogen inc.

mike hencke

1-781-464-2442

ir@biogen.com

tokyo and cambridge, mass., january 30, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that an application for manufacturing and marketing approval for lecanemab (generic name, u.s. brand name: leqembi™), an anti-amyloid-β (aβ) protofibril* antibody, in japan has been designated for priority review by the japanese ministry of health, labour and welfare (mhlw). priority review in japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for priority review, the target total review period is shortened.

in japan, eisai submitted the manufacturing and marketing approval for lecanemab to the pharmaceuticals and medical devices agency (pmda) on january 16, 2023. this application is based on the results of the phase iii clarity ad study and the phase iib clinical study (study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early ad.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at and simultaneously published in , a peer-reviewed medical journal.

in the u.s., lecanemab was granted accelerated approval as a treatment for ad by the u.s. food and drug administration (fda) on january 6, 2023. on the same day, eisai submitted a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway. in europe, eisai submitted a marketing authorization application (maa) to the european medicines agency (ema) on january 9, 2023 and accepted on january 26, 2023. in china, eisai initiated submission of data for a bla to the national medical products administration (nmpa) in december 2022.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

highest ranked global pharmaceutical company

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been listed in the 2023 global 100 most sustainable corporations in the world (global 100), a global ranking by canada-based media and investment advisory company, corporate knights, inc. this marks eisai’s seventh inclusion on the list. ranked 53rd, eisai was the highest ranking company among global pharmaceutical companies.

 

the global 100 evaluates the sustainability of more than 6,000 of the world’s major corporations based on various corporate initiatives in areas such as esg (environment, society and governance). since 2005, those companies ranking among the top 100 in the world have been announced each year. the global 100 is based on up to 25 key performance indicators covering esg initiatives, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels. eisai was highly evaluated, particularly in indicators for enhancing employee value such as safe work environment, sick leave support system and employee retention rate.

 

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

 

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

accelerated approval is based on phase 2 data showing a reduction in amyloid-beta plaques in early ad patients treated with leqembi™

treatment with leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials

 

tokyo and cambridge, mass., january 7, 2023 eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, eisai) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, biogen) announced today that under the accelerated approval pathway the u.s. food and drug administration (fda) has approved lecanemabirmb (brand name in the u.s.: leqembi™) 100 mg/ml injection for intravenous use, a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (“protofibril”)* and insoluble forms of amyloid beta (aβ) for the treatment of alzheimer’s disease (ad). the approval is based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad. using the recently published data from the large global confirmatory phase 3 clinical trial, clarity ad, eisai will work quickly to file a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway.

 

indication
leqembi is indicated for the treatment of alzheimer’s disease. treatment with leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. this indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with leqembi. continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.


dosage and administration (patient selection, dosing instructions, monitoring and dosing interruption for aria)
the recommended dosage of leqembi is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of aβ pathology prior to initiating treatment. enhanced clinical vigilance for amyloidrelated imaging abnormalities (aria) is recommended during the first 14 weeks of treatment with leqembi. baseline, recent (within one year) brain mri prior to initiating treatment with leqembi and periodic monitoring with mri prior to the 5th, 7th, and 14th infusions should be obtained.

 

adverse reactions
the safety of leqembi has been evaluated in 763 patients who received at least one dose of leqembi in study 201. the most common adverse reactions reported in at least 5% of patients treated with leqembi 10 mg/kg biweekly (n=161) and at least 2% higher incidence than patients on placebo (n=245) were infusionrelated reactions (leqembi 20%; placebo 3%), headache (leqembi 14%; placebo 10%), ariae (leqembi 10%; placebo 1%), cough (leqembi, 9%; placebo, 5%) and diarrhea (leqembi, 8%; placebo, 5%). the most common adverse reaction leading to discontinuation of leqembi was infusionrelated reactions that led to discontinuation in 2% (4/161) of patients treated with leqembi compared to 1% (2/245) of patients on placebo.


“the fda’s approval of leqembi under the accelerated approval pathway is an important milestone in eisai’s four decades of research in alzheimer’s disease and reflects our continued commitment to alleviating the burden of alzheimer’s disease for patients and their families. eisai has made great efforts to understand the reality of the challenges and concerns facing patients and their families who are living in the various stages of alzheimer’s disease, and we are incredibly pleased to offer leqembi as a new treatment option to help with the tremendous unmet needs of this community,” said haruo naito, chief executive officer at eisai co., ltd. “the challenges of alzheimer’s disease reach beyond medical implications for patients and considerations for their families, but also impact society as a whole through reduced productivity, elevated social costs and anxiety. upon receiving this accelerated approval, we will focus on providing important information on proper usage of leqembi to healthcare professionals. eisai will also engage with various payers to provide access to leqembi, offer a patient support program, and
will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early alzheimer’s disease.”


“the approval of leqembi provides new hope to patients with alzheimer’s disease. patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. our focus now is on the path forward, working alongside eisai with the goal of making leqembi available to patients who may benefit from this treatment as soon as possible,” said christopher a. viehbacher, president and chief executive officer of biogen. “this approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex disease. eisai and biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from alzheimer’s, and we know that this commitment must and will continue in the fight against alzheimer’s disease.”


media contacts:
eisai co., ltd.
public relations department
tel: 81 (0)338175120


eisai inc. (u.s.)
libby holman
12017531945
libby_holman@eisai.com

 

eisai europe, ltd.
(uk, europe, australia, new zealand and russia)
emea communications department
44 (0) 786 601 1272
emea-comms@eisai.net


biogen inc.
natacha gassenbach
18577776573
public.affairs@biogen.com

investor contacts:
eisai co., ltd.
investor relations department
tel: 81 (0) 338175122


biogen inc.
mike hencke
17814642442
ir@biogen.com

tokyo and cambridge, eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that eisai has initiated submission of data for biologics license application (bla) to the national medical products administration (nmpa) of china for lecanemab (development code: ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody.

the registration category of lecanemab was designated as a category 1 drug (innovative biologics not approved in china or any other countries).

the data submitted in this package includes data from the phase ii clinical trial (study 201) in mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed aβ accumulation in the brain and the top-line data of the large global phase iii clarity ad study. eisai will submit additional data including full data of the clarity ad study, as directed by the nmpa.

lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at , and simultaneously published in , peer-reviewed medical journals.

in the u.s., lecanemab was granted breakthrough therapy and fast track designations by the u.s. food and drug administration (fda) in june and december 2021, respectively. in july 2022, the fda accepted eisai’s bla for lecanemab under the accelerated approval pathway and granted it priority review. the prescription drug user fee act (pdufa) action date is january 6, 2023. eisai aims to file for traditional approval in the u.s. and for marketing authorization applications in japan and the europe by the end of eisai’s fy2022, which ends march 31, 2023.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

contacts
media contact:

eisai co., ltd.

public relations department

tel: 81-(0)3-3817-5120

 

 

investor contact:

eisai co., ltd.

investor relations department

tel: 81-(0)3-3817-5122

media contact:

biogen inc.

natacha gassenbach

1-857-777-6573

public.affairs@biogen.com

 

investor contact:

biogen inc.

mike hencke

1-781-464-2442

ir@biogen.com

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