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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

tokyo and osaka, december 22, 2022  – astellas pharma inc. (tse: 4503, president and ceo: kenji yasukawa, “astellas”), eisai co., ltd. (tse: 4523, ceo: haruo naito, “eisai”), daiichi sankyo company, limited (tse: 4568, president : sunao manabe, “daiichi sankyo”) and takeda pharmaceutical company limited. (tse: 4502 / nyse:tak, president and ceo christophe weber, “takeda”) today announced that the four companies have agreed the collaboration to reduce environmental burden in the field of pharmaceutical packaging.

based on the agreement, the four companies will aim to promote the use of more environmentaly friendly packaging for pharmaceutical products by sharing knowledge on packaging technologies to reduce environmental burden, such as blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.

astellas, eisai, daiichi sankyo, and takeda aim to ensure that society benefits from this collaboration to harmonize corporate activities with the global environment. in the future, the four companies expect to expand this collaboration beyond the four companies by calling on other companies in order to reduce further environmental burden.

 

■  initiatives for sustainability (environment) of each company

astellas has set “deepen our engagement in sustainability” as one of the strategic goals in its . the reduction of environmental burden is one of astellas’ priority themes within sustainability. for more information on specific initiatives, please visit .

eisai established the “eisai environmental management vision” this fiscal year, and in addition to climate change countermeasures aimed at achieving carbon neutrality by fiscal 2040, eisai has formed a medium- to long-term plan for environmental issues including efficient use of water and recycling of resources, and will work to further advance these efforts. to learn more about our environmental initiatives, please visit .

as a healthcare company with the purpose “to contribute to the enrichment of quality of life around the world,” daiichi sankyo considers global environmental conservation, which is the basis of life and livelihood, as a key management issue () and promotes environmental management. for more information on specific initiatives, please visit .

at takeda, “purpose-led sustainability” is about creating both business and societal value through its core business. takeda continues to reduce our operational carbon footprint and are now committed to achieving net-zero ghg emissions for scopes 1 and 2 before 2035 and for scope 3 before 2040. for more information, see our .

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an agreement to transfer the united states (u.s.) commercial rights for the anti-epileptic drug (aed) fycompa® (generic name: perampanel) ciii to catalyst pharmaceuticals, inc. (headquarters: the united states, “catalyst pharmaceuticals”), as well as to provide catalyst pharmaceuticals with an exclusive negotiation period for an asset in eisai’s epilepsy pipeline. eisai will maintain its rights to fycompa in countries and regions outside the u.s. and continue to contribute to patients with epilepsy. closing of the transaction is contingent on completion of review under antitrust laws in the u.s.

the agreement will provide the opportunity for eisai’s neuroscience team to focus on its long-term strategic priorities on the research, development, and commercialization of its alzheimer’s disease portfolio. eisai remains committed to drug discovery and research for anti-epileptogenesis through the modulation of neuroinflammation or lipid metabolism in glia cells, as well as the application of new technologies including spatial rna-sequence. research is a crucial aspect of eisai’s aim to gain a deeper understanding of human brain biology and technologies that may also ultimately lead to broader neuroscience discoveries.

in the u.s., fycompa was approved in 2012 and has been prescribed to more than 50,000 patients. catalyst pharmaceuticals is a company focused on developing therapies for rare neuromuscular as well as neurological disorders, and is increasing its presence in neurology in the u.s. the agreement is expected to maximize the patient value of fycompa in the u.s. due to its strong commitment to patients living with epilepsy.

under the terms of the agreement, eisai will receive a contractual up-front payment of $160 million (usd) upon closing of the transaction. in addition, milestone payments and royalties may be received in the future. eisai will continue to be responsible for the manufacture and supply of fycompa to global markets including the u.s. eisai’s u.s. subsidiary eisai inc. will provide transition services for a period to ensure patients continue to have access to this important medicine.

as a result of this transaction, eisai anticipates no changes to its consolidated financial forecast for the period ended march 31, 2023.

driven by our hhc concept, eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: neurology, oncology and global health. as an hhceco company, eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries.

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

media inquiries:

eisai inc. (u.s.)

christopher vancheri

551-305-0050

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that eisai and washington university school of medicine in st. louis have entered into a comprehensive research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders, including alzheimer’s disease (ad) and parkinson’s disease (pd).

washington university is world leading in research on prevention, diagnosis, biomarkers and treatment of neurodegenerative diseases. the two organizations have been collaborating in ad research. the phase ii/iii tau nexgen study conducted by the dominantly inherited alzheimer network trials unit (dian-tu), led by the university’s school of medicine, is exploring the safety, tolerability, biomarkers and cognitive efficacy of eisai’s anti-mtbr (microtubule binding region) tau antibody e2814 for the treatment of dominantly inherited alzheimer’s disease (diad). in this study, the anti-amyloid beta (aβ) protofibril antibody lecanemab (generic name, development code: ban2401) was selected as the background anti-amyloid agent.

the collaboration strategically combines washington university scientists’ expertise in the fundamental and clinical research in neurodegenerative diseases, such as dementia, with eisai’s extensive experience in drug discovery and development. using human biology, the aim is to create multiple novel therapeutic candidates as well as discover and identify biomarkers within the next five years. eisai will have the option rights to develop and commercialize any compounds and biomarkers that meet certain criteria in terms of research and development milestones. in the case that eisai chooses to exercise the options, eisai will pay washington university milestone payments and royalties on future sales of each licensed compounds.

dr. teiji kimura, ph.d., academia and industry alliance officer, deep human biology learning (dhbl) office of eisai, commented, “patients living with neurodegenerative diseases, including alzheimer’s disease and parkinson’s disease, struggle with critical unmet medical needs, which is the reason neurology is a key therapeutic area for eisai. by collaborating with world-leading research institutions such as washington university in st. louis, eisai is working to fulfill our human health care mission and provide potential new and targeted disease-modifying therapies with the ultimate goal of achieving a world free of neurodegenerative disease.”

 

media inquiries:

public relations department, eisai co., ltd.

81-(0)3-3817-5120

eisai inc (u.s.)

libby holman 201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (halaven®, “eribulin”) will be presented during the 2022 san antonio breast cancer symposium (sabcs), which is taking place virtually and in-person in san antonio, texas from december 6-10.

 

eisai will present five eribulin-related abstracts, including a post hoc subgroup analysis from two pivotal phase 3 studies (embrace and study 301), as well as:

–    real world use of eribulin following treatment with a p13k inhibitor, mostly in people with hormone receptor (hr)-positive/her2-negative metastatic breast cancer.

–    preclinical data exploring a liposomal formulation of eribulin, in a phase 1 expansion cohort for breast cancer, versus eribulin at the same dose, in patient-derived breast cancer xenografts.

 

“we continue to relentlessly pursue research that provides useful insights for people living with breast cancer,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “a big part of this commitment is the ongoing sharing of our preclinical and clinical data with eribulin.”

 

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.

 

eisai presentations at the 2022 sabcs are as follows:

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