EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER’S DISEASE UNDER THE ACCELERATED APPROVAL PATHWAY

TOKYO and CAMBRIDGE, Mass., Might 9, 2022 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Company headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) introduced as we speak that Eisai has accomplished the rolling submission to the U.S. Meals and Drug Administration (FDA) of a Biologics License Utility (BLA) beneath the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for the therapy of gentle cognitive impairment (MCI) as a consequence of Alzheimer’s illness (AD) and gentle AD (collectively referred to as early AD) with confirmed presence of amyloid pathology within the mind. As a part of the finished rolling submission, Eisai has requested Precedence Evaluation. If the FDA accepts the BLA, the Prescription Drug Consumer Price Act (PDUFA) motion date (goal date for completion of examination) will likely be set. Whereas Eisai is at present submitting lecanemab beneath the accelerated approval pathway, the lecanemab Part 3 confirmatory Readability AD scientific trial performed with 1,795 sufferers will report out within the Fall of 2022. The FDA has agreed that the outcomes of Readability AD, when accomplished, can function the confirmatory examine to confirm the scientific good thing about lecanemab. Dependent upon the outcomes of the Readability AD scientific trial, Eisai might submit for full approval of lecanemab to the FDA throughout fiscal 12 months 2022.

The BLA submission for lecanemab is predicated on scientific, biomarker and security knowledge from the proof-of-concept Part 2b (Research 201 Core) in 856 individuals with early AD with confirmed presence of amyloid pathology, biomarker and security knowledge from the Research 201 OLE (open-label extension examine, 180 topics), and blinded security knowledge from the confirmatory Readability AD Part 3 examine (1,795 topics). The big variety of contributors throughout these research supplies the FDA with intensive security knowledge. Research 201 explored the affect of therapy with lecanemab on lowering amyloid plaque and scientific decline. At 18 months of therapy, 10 mg/kg biweekly lecanemab decreased mind amyloid by a imply of 0.306 SUVr items (from a baseline imply of 1.37), and over 80% of topics turned amyloid unfavorable by visible learn. Moreover, the extent of discount in amyloid was correlated with slower scientific decline on ADCOMS (Alzheimer’s Illness Composite Rating), CDR-SB (Medical Dementia Ranking-Sum-of-Bins), and ADAS-cog (Alzheimer Illness Evaluation Scale-Cognitive Subscale) on the therapy group and affected person degree. Within the Core examine, the general fee of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adversarial occasion related to anti-amyloid beta antibodies therapies was 9.9% (16/161) of sufferers handled with lecanemab 10 mg/kg biweekly in contrast with 0.8% (2/245) of placebo sufferers. The outcomes from Research 201 had been revealed in a peer-reviewed journal Alzheimer’s Analysis and Remedy in April 2021.

“We want to thank the individuals dwelling with early AD and the healthcare professionals who participated within the lecanemab 201 examine for his or her cooperation permitting completion of this BLA to the U.S. FDA. Alzheimer’s illness is a progressive and devastating illness with few therapy choices,” mentioned Haruo Naito, Chief Government Officer at Eisai Co., Ltd. “Eisai workers have frolicked with individuals dwelling with Alzheimer’s illness and their households to actually perceive their emotions and challenges and have been working to create new remedies for a few years. Our complete drugs creation method alongside the Alzheimer’s illness continuum displays Eisai’s long-term dedication to offering revolutionary remedies to the individuals dwelling with AD, their households and healthcare professionals who urgently want new therapy choices.”

“With Alzheimer’s illness, sufferers and their family members haven’t got the posh of time. There is a gigantic unmet want on this house, and we proceed to make progress in advancing further therapy choices for individuals dwelling with this devastating illness,” mentioned Michel Vounatsos, Chief Government Officer at Biogen. “Anti-amyloid antibodies are a brand new wave of necessary medicines, which might present sufferers and their physicians extra choices in addressing this advanced illness.”

Lecanemab was granted Breakthrough Remedy and Quick Observe designations by the FDA in June and December 2021, respectively. In March 2022, Eisai initiated submission of utility knowledge to the Prescription drugs and Medical Gadgets Company (PMDA) beneath the prior evaluation session system in Japan with the goal of acquiring early approval for lecanemab, and goals to file for the manufacturing and advertising approval based mostly on the outcomes of Readability AD throughout Eisai’s fiscal 12 months 2022.

Eisai serves because the lead of lecanemab growth and regulatory submissions globally with each Eisai and Biogen co-commercializing and co-promoting the product and Eisai having remaining decision-making authority.

[Notes to editors]

1.   About Lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s illness (AD) that’s the results of a strategic analysis alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and remove soluble, poisonous amyloid-beta (Aβ) aggregates (protofibrils) which are thought to contribute to the neurodegenerative course of in AD. As such, lecanemab might have the potential to impact illness pathology and to decelerate the development of the illness. At the moment, lecanemab is being developed as the one anti- Aβ antibody that can be utilized for the therapy of early AD with out the necessity for titration. With regard to the outcomes from pre-specified evaluation at 18 months of therapy, Research 201 demonstrated discount of mind Aβ accumulation (P<0.0001) and slowing of illness development measured by ADCOMS* (P<0.05) in early AD sufferers. The examine didn’t obtain its major consequence measure** at 12 months of therapy. The Research 201 open-label extension was initiated after completion of the Core interval and a Hole interval off therapy of 9-59 months (common of 24 months, n=180 from core examine enrolled) to judge security and efficacy, and is underway.

At the moment, lecanemab is being studied in a confirmatory Part 3 scientific examine in symptomatic early AD (Readability-AD), following the end result of the Part 2 scientific examine (Research 201). Since July 2020 the Part 3 scientific examine (AHEAD 3-45) for people with preclinical AD, that means they’re clinically regular and have intermediate or elevated ranges of amyloid of their brains, is ongoing. AHEAD 3-45 is performed as a public-private partnership between the Alzheimer’s Medical Trial Consortium that gives the infrastructure for tutorial scientific trials in AD and associated dementias within the U.S, funded by the Nationwide Institute on Growing older, a part of the Nationwide Institutes of Well being, Eisai and Biogen. Since January 2022, the Tau NexGen scientific examine for Dominantly Inherited Alzheimer’s illness (DIAD), that’s performed by Dominantly Inherited Alzheimer Community Trials Unit (DIAN-TU), led by Washington College College of Medication in St. Louis, is ongoing.  Moreover, Eisai has initiated a lecanemab subcutaneous dosing Part 1 examine. Eisai obtained the worldwide rights to check, develop, manufacture and market lecanemab for the therapy of AD pursuant to an settlement concluded with BioArctic in December 2007.

* Developed by Eisai, ADCOMS (AD Composite Rating) combines gadgets from the ADAS-Cog (Alzheimer’s Illness Evaluation Scale-cognitive subscale), CDR (Medical Dementia Ranking) and the MMSE (Mini-Psychological State Examination) scales to allow a delicate detection of modifications in scientific features of early AD signs and modifications in reminiscence. The ADCOMS scale ranges from a rating of 0.00 to 1.97, with greater rating indicating larger impairment.

** An 80% or greater estimated chance of demonstrating 25% or larger slowing in scientific decline at 12 months therapy measured by ADCOMS from baseline in comparison with placebo.

2.   In regards to the Collaboration between Eisai and Biogen for Alzheimer’s Illness
Eisai and Biogen are collaborating on the joint growth and commercialization of AD remedies. Eisai serves because the lead within the co-development of lecanemab.

3.   In regards to the Collaboration between Eisai and BioArctic for Alzheimer’s Illness
Since 2005, BioArctic has had a long-term collaboration with Eisai relating to the event and commercialization of medicine for the therapy of AD. The commercialization settlement on the lecanemab antibody was signed in December 2007, and the event and commercialization settlement on the antibody lecanemab back-up for AD, which was signed in Might 2015. Eisai is accountable for the scientific growth, utility for market approval and commercialization of the merchandise for AD. BioArctic has no growth prices for lecanemab in AD.

4.   About Eisai Co., Ltd.
Eisai Co., Ltd. is a number one world pharmaceutical firm headquartered in Japan. Eisai’s company philosophy is predicated on the human well being care (hhc) idea, which is to present first thought to sufferers and their households, and to extend the advantages that well being care supplies to them. With a world community of R&D services, manufacturing websites and advertising subsidiaries, we attempt to comprehend our hhc philosophy by delivering revolutionary merchandise to focus on illnesses with excessive unmet medical wants, with a specific focus in our strategic areas of Neurology and Oncology.

Leveraging the expertise gained from the event and advertising of a therapy for Alzheimer’s illness, Eisai goals to determine the “Eisai Dementia Platform.” By means of this platform, Eisai plans to ship novel advantages to these dwelling with dementia and their households by developing a “Dementia Ecosystem,” by collaborating with companions reminiscent of medical organizations, diagnostic growth corporations, analysis organizations, and bio-ventures along with personal insurance coverage companies, finance industries, health golf equipment, car makers, retailers, and care services. For extra details about Eisai Co., Ltd., please go to https://www.eisai.com.

5.   About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide revolutionary therapies for individuals dwelling with severe neurological illnesses in addition to associated therapeutic adjacencies. One of many world’s first world biotechnology corporations, Biogen was based in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. At present, Biogen has a main portfolio of medicines to deal with a number of sclerosis, has launched the primary authorized therapy for spinal muscular atrophy, and is offering the primary and solely authorized therapy to deal with a defining pathology of Alzheimer’s illness. Biogen can also be commercializing biosimilars and specializing in advancing the business’s most diversified pipeline in neuroscience that can rework the usual of look after sufferers in a number of areas of excessive unmet want. 

In 2020, Biogen launched a daring 20-year, $250 million initiative to deal with the deeply interrelated problems with local weather, well being, and fairness. Wholesome Local weather, Wholesome Lives™ goals to remove fossil fuels throughout the corporate’s operations, construct collaborations with famend establishments to advance the science to enhance human well being outcomes, and help underserved communities. 

The corporate routinely posts data which may be necessary to traders on our web site at www.biogen.com. To be taught extra, please go to www.biogen.com and observe Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.

Biogen Secure Harbor
This information launch incorporates forward-looking statements, together with statements made pursuant to the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995, in regards to the potential scientific results of lecanemab; the potential advantages, security and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the anticipated knowledge readout for the Readability AD examine; the therapy of Alzheimer’s illness; the anticipated advantages and potential of Biogen’s collaboration preparations with Eisai; the potential of Biogen’s industrial enterprise and pipeline applications, together with lecanemab; and dangers and uncertainties related to drug growth and commercialization. These statements could also be recognized by phrases reminiscent of “goal,” “anticipate,” “imagine,” “might,” “estimate,” “anticipate,” “forecast,” “intend,” “might,” “plan,” “potential,” “potential,” “will,” “would” and different phrases and phrases of comparable that means. Drug growth and commercialization contain a excessive diploma of danger, and solely a small variety of analysis and growth applications end in commercialization of a product. Ends in early-stage scientific research will not be indicative of full outcomes or outcomes from later stage or bigger scale scientific research and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements or the scientific knowledge offered.

These statements contain dangers and uncertainties that might trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation sudden considerations that will come up from further knowledge, evaluation or outcomes obtained throughout scientific research, together with the Readability AD scientific trial and AHEAD 3-45 examine; the prevalence of adversarial security occasions; dangers of sudden prices or delays; the danger of different sudden hurdles; regulatory submissions might take longer or be tougher to finish than anticipated; regulatory authorities might require further data or additional research, or might fail or refuse to approve or might delay approval of Biogen’s drug candidates, together with lecanemab; precise timing and content material of submissions to and selections made by the regulatory authorities relating to lecanemab; uncertainty of success within the growth and potential commercialization of lecanemab; failure to guard and implement Biogen’s knowledge, mental property and different proprietary rights and uncertainties regarding mental property claims and challenges; product legal responsibility claims; third celebration collaboration dangers; and the direct and oblique impacts of the continued COVID-19 pandemic on Biogen’s enterprise, outcomes of operations and monetary situation. The foregoing units forth many, however not all, of the elements that might trigger precise outcomes to vary from Biogen’s expectations in any forward-looking assertion. Traders ought to think about this cautionary assertion in addition to the danger elements recognized in Biogen’s most up-to-date annual or quarterly report and in different reviews Biogen has filed with the U.S. Securities and Trade Fee. These statements are based mostly on Biogen’s present beliefs and expectations and communicate solely as of the date of this information launch. Biogen doesn’t undertake any obligation to publicly replace any forward-looking statements, whether or not because of new data, future developments or in any other case.

SOURCE Eisai Inc.