EISAI FILES MARKETING AUTHORIZATION APPLICATION FOR ANTI-AMYLOID-BETA PROTOFIBRIL ANTIBODY LECANEMAB FOR EARLY ALZHEIMER’S DISEASE IN JAPAN

TOKYO and CAMBRIDGE, Mass., Jan. 15, 2023 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Company headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) introduced as we speak that Eisai has submitted a advertising authorization utility for lecanemab (Model Title within the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril¹ antibody for the therapy of gentle cognitive impairment (MCI) attributable to Alzheimer’s illness (AD) and gentle AD dementia (collectively referred to as early AD) with confirmed presence of amyloid pathology within the mind to the Prescription drugs and Medical Units Company (PMDA).

This utility relies on the outcomes of the Part III Readability AD examine and Part IIb scientific examine (Research 201), which demonstrated the lecanemab therapy confirmed a discount of scientific decline in early AD. Previous to submitting this utility, Eisai utilized the prior evaluation session system of PMDA, with the intention of shortening the evaluate interval for lecanemab.

Within the Readability AD examine, lecanemab therapy resulted in extremely statistically important outcomes, lowering scientific decline on the worldwide cognitive and purposeful scale as the first endpoint (CDR-SB²: Medical Dementia Ranking-Sum of Bins) as early as six months, and over time throughout all time factors. All key secondary endpoints additionally confirmed extremely statistically important outcomes. Particularly, therapy with lecanemab confirmed a statistically important discount in amyloid plaque burden in any respect timepoints beginning at 3 months within the amyloid PET examine and statistically considerably slowed decline of actions of day by day dwelling on ADCS MCI-ADL³. The most typical antagonistic occasions (>10%) within the lecanemab group have been infusion reactions, ARIA-H (mixed cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

In November 2022, the outcomes of Readability AD examine have been offered on the fifteenth Medical Trials on Alzheimer’s Illness (CTAD) convention and concurrently printed within the peer-reviewed medical journal the New England Journal of Drugs.

Within the U.S., lecanemab was granted accelerated approval as a therapy for AD by the U.S. Meals and Drug Administration (FDA) on January 6, 2023. On the identical day, Eisai submitted a Supplemental Biologics License Utility (sBLA) to the FDA for approval underneath the standard pathway. In Europe, Eisai submitted advertising authorization utility (MAA) to the European Medicines Company (EMA) on January 9, 2023. In China, Eisai initiated submission of knowledge for BLA to the Nationwide Medical Merchandise Administration (NMPA) of China in December 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 last decision-making authority.

This launch discusses investigational makes use of of an agent in growth and isn’t supposed to convey conclusions about efficacy or security. There isn’t any assure that such an investigational agent will efficiently acquire well being authority approval.

[Notes to editors]

1.  INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
INDICATION
LEQEMBI is indicated for the therapy of Alzheimer’s illness. Remedy with LEQEMBI ought to be initiated in sufferers with gentle cognitive impairment or gentle dementia stage of illness, the inhabitants by which therapy was initiated in scientific trials. There aren’t any security or effectiveness information on initiating therapy at earlier or later phases of the illness than have been studied. This indication is accredited underneath accelerated approval primarily based on discount in amyloid beta plaques noticed in sufferers handled with LEQEMBI. Continued approval for this indication could also be contingent upon verification of scientific profit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Amyloid Associated Imaging Abnormalities
LEQEMBI may cause amyloid associated imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H). ARIA-E could be noticed on MRI as mind edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. ARIA is often asymptomatic, though severe and life-threatening occasions, together with seizure and standing epilepticus, not often can happen. Reported signs related to ARIA might embrace headache, confusion, visible modifications, dizziness, nausea, and gait problem. Focal neurologic deficits might also happen. Signs related to ARIA often resolve over time.

ARIA Monitoring and Dose Administration Pointers

• Acquire current (inside one 12 months) mind magnetic resonance imaging (MRI) previous to initiating therapy with LEQEMBI. Acquire an MRI previous to the fifth, seventh, and 14th infusions.

• Suggestions for dosing in sufferers with ARIA-E and ARIA-H rely on scientific signs and radiographic severity. Relying on ARIA severity, use scientific judgment in contemplating whether or not to proceed dosing, quickly discontinue therapy, or completely discontinue LEQEMBI.

• Enhanced scientific vigilance for ARIA is really helpful in the course of the first 14 weeks of therapy with LEQEMBI. If a affected person experiences signs suggestive of ARIA, scientific analysis ought to be carried out, together with MRI if indicated. If ARIA is noticed on MRI, cautious scientific analysis ought to be carried out previous to persevering with therapy.

• There isn’t any expertise in sufferers who continued dosing via symptomatic ARIA-E or via asymptomatic, however radiographically extreme, ARIA-E. There’s restricted expertise in sufferers who continued dosing via asymptomatic however radiographically gentle to reasonable ARIA-E. There are restricted information in dosing sufferers who skilled recurrent ARIA-E.

Incidence of ARIA

• In Research 1 (Research 201), symptomatic ARIA occurred in 3% (5/161) of LEQEMBI-treated sufferers. Medical signs related to ARIA resolved in 80% of sufferers in the course of the interval of statement.

• Together with asymptomatic instances, ARIA was noticed in LEQEMBI: 12% (20/161); placebo: 5% (13/245). ARIA-E was noticed in LEQEMBI: 10% (16/161); placebo: 1% (2/245). ARIA-H was noticed in LEQEMBI: 6% (10/161); placebo: 5% (12/245). There was no enhance in remoted ARIA-H for LEQEMBI in comparison with placebo.

• Intracerebral hemorrhage >1 cm in diameter was reported after one therapy in LEQEMBI: 1 affected person; placebo: zero sufferers. Occasions of intracerebral hemorrhage, together with deadly occasions, in sufferers taking LEQEMBI have additionally been reported in different research.

Apolipoprotein E ε4 (ApoE ε4) Provider Standing and Threat of ARIA

• In Research 1, 6% (10/161) of sufferers within the LEQEMBI group have been ApoE ε4 homozygotes, 24% (39/161) have been heterozygotes, and 70% (112/161) have been noncarriers.

• The incidence of ARIA was larger in ApoE ε4 homozygotes than in heterozygotes and noncarriers amongst sufferers handled with LEQEMBI. Of the 5 LEQEMBI-treated sufferers who had symptomatic ARIA, 4 have been ApoE ε4 homozygotes, 2 of whom skilled extreme signs. An elevated incidence of symptomatic and general ARIA in ApoE ε4 homozygotes in comparison with heterozygotes and noncarriers in LEQEMBI-treated sufferers has been reported in different research.

• The suggestions on administration of ARIA don’t differ between ApoE ε4 carriers and noncarriers.

• Think about testing for ApoE ε4 standing to tell the chance of growing ARIA when deciding to provoke therapy with LEQEMBI.

Radiographic Findings

• Nearly all of ARIA-E radiographic occasions occurred early in therapy (throughout the first 7 doses), though ARIA can happen at any time and sufferers can have greater than 1 episode. The utmost radiographic severity of ARIA-E in sufferers handled with LEQEMBI was gentle in 4% (7/161) of sufferers, reasonable in 4% (7/161) of sufferers, and extreme in 1% (2/161) of sufferers. Decision on MRI occurred in 62% of ARIA-E sufferers by 12 weeks, 81% by 21 weeks, and 94% general after detection. The utmost radiographic severity of ARIA-H microhemorrhage in sufferers handled with LEQEMBI was gentle in 4% (7/161) of sufferers and extreme in 1% (2/161) of sufferers; 1 of the ten sufferers with ARIA-H had gentle superficial siderosis.

Concomitant Antithrombotic Treatment and Different Threat Components for Intracerebral Hemorrhage

• Sufferers have been excluded from enrollment in Research 1 for baseline use of anticoagulant medicines. Antiplatelet medicines resembling aspirin and clopidogrel have been allowed. If anticoagulant medicine was used due to intercurrent medical occasions that required therapy for ≤4 weeks, therapy with LEQEMBI was to be quickly suspended.

• Most exposures to antithrombotic medicines have been to aspirin; few sufferers have been uncovered to different antiplatelet medicine or anticoagulants, limiting any significant conclusions concerning the threat of ARIA or intracerebral hemorrhage in sufferers taking different antiplatelet medicine or anticoagulants. As a result of intracerebral hemorrhages >1 cm in diameter have been noticed in sufferers taking LEQEMBI, extra warning ought to be exercised when contemplating the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a affected person already being handled with LEQEMBI.

• Sufferers have been excluded from enrollment in Research 1 for the next threat elements for intracerebral hemorrhage: prior cerebral hemorrhage >1 cm in biggest diameter, greater than 4 microhemorrhages, superficial siderosis, proof of vasogenic edema, proof of cerebral contusion, aneurysm, vascular malformation, infective lesions, a number of lacunar infarcts or stroke involving a serious vascular territory, and extreme small vessel or white matter illness. Warning ought to be exercised when contemplating using LEQEMBI in sufferers with these threat elements.

Infusion-Associated Reactions

• Infusion-related reactions have been noticed in LEQEMBI: 20% (32/161); placebo: 3% (8/245), and nearly all of instances in LEQEMBI-treated sufferers (88%, 28/32) occurred with the primary infusion. All infusion-related reactions have been gentle (56%) or reasonable (44%) in severity. Infusion-related reactions resulted in discontinuations in 2% (4/161) of sufferers handled with LEQEMBI. Signs of infusion-related reactions included fever and flu-like signs (chills, generalized aches, feeling shaky, and joint ache), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

• After the primary infusion, 38% of LEQEMBI-treated sufferers had transient decreased lymphocyte counts to <0.9 x10⁹/L in comparison with 2% on placebo, and 22% of LEQEMBI-treated sufferers had transient elevated neutrophil counts to >7.9 x10⁹/L in comparison with 1% on placebo.

• Within the occasion of an infusion-related response, the infusion charge could also be decreased, or the infusion could also be discontinued, and applicable remedy initiated as clinically indicated. Prophylactic therapy with antihistamines, acetaminophen, nonsteroidal anti-inflammatory medicine, or corticosteroids previous to future infusions could also be thought-about.

ADVERSE REACTIONS

• In Research 1, 15% of LEQEMBI-treated sufferers, in comparison with 6% of placebo-treated sufferers, stopped examine therapy due to an antagonistic response. The most typical antagonistic response resulting in discontinuation of LEQEMBI was infusion-related reactions that led to discontinuation in 2% (4/161) of sufferers handled with LEQEMBI in comparison with 1% (2/245) of sufferers on placebo.

• The most typical antagonistic reactions reported in ≥5% of sufferers handled with LEQEMBI (N=161) and ≥2% larger than placebo (N=245) in Research 1 have been infusion-related reactions (LEQEMBI: 20%; placebo: 3%), headache (LEQEMBI: 14%; placebo: 10%), ARIA-E (LEQEMBI: 10%; placebo: 1%), cough (LEQEMBI: 9%; placebo: 5%), and diarrhea (LEQEMBI: 8%; placebo: 5%).

Please see full Prescribing Info within the U.S.

2.  About Lecanemab
Lecanemab (Model Title within the U.S.: LEQEMBI™) is the results of a strategic analysis alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed towards aggregated soluble (protofibril) and insoluble types of amyloid-beta (Aβ). Within the U.S., LEQEMBI was granted accelerated approval by the U.S. Meals and Drug Administration (FDA) on January 6, 2023. LEQEMBI is indicated for the therapy of Alzheimer’s illness (AD) within the U.S. Remedy with LEQEMBI ought to be initiated in sufferers with gentle cognitive impairment or gentle dementia stage of illness, the inhabitants by which therapy was initiated in scientific trials. There aren’t any security or effectiveness information on initiating therapy at earlier or later phases of the illness than have been studied. This indication is accredited underneath accelerated approval primarily based on discount in Aβ plaques noticed in sufferers handled with LEQEMBI. Continued approval for this indication could also be contingent upon verification of scientific profit in a confirmatory trial. Eisai submitted a Supplemental Biologics License Utility (sBLA) to the FDA for approval underneath the standard pathway on January 6, 2023. In Europe, Eisai submitted advertising authorization utility (MAA) to the European Medicines Company (EMA) on January 9, 2023. In China, Eisai initiated submission of knowledge for BLA to the Nationwide Medical Merchandise Administration (NMPA) of China in December 2022.

Eisai has accomplished lecanemab subcutaneous bioavailability examine, and subcutaneous dosing is at the moment being evaluated within the Readability AD OLE.

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 carried out as a public-private partnership between the Alzheimer’s Medical Trial Consortium that gives the infrastructure for educational scientific trials in AD and associated dementias within the U.S, funded by the Nationwide Institute on Getting older, a part of the Nationwide Institutes of Well being, Eisai and Biogen.

Since January 2022, the Tau NexGen scientific examine for Dominantly Inherited AD (DIAD), that’s carried out by Dominantly Inherited Alzheimer Community Trials Unit (DIAN-TU), led by Washington College College of Drugs in St. Louis, is ongoing.

3.  About Part IIb (Research 201) examine and Part III Readability AD examine
Part IIb scientific examine (Research 201) was carried out as a double-blind, parallel-group, dose-finding examine of lecanemab or placebo for 18 months in 856 folks dwelling with early AD (34 of whom have been Japanese). Lecanemab therapy resulted in a dose-dependent, longitudinal, and important discount in PET SUVR, which assesses amyloid-β accumulation within the mind, in comparison with placebo. At 18 months, ADCOMS⁴, CDR-SB, and ADAS-cog14⁵ confirmed a dose-dependent lowering scientific decline, with suppression charges of 29.7%, 26.5%, and 47.2% within the 10 mg/kg bi-weekly therapy, respectively. The examine didn’t obtain its major consequence measure⁶ at 12 months of therapy. The most typical antagonistic occasions occurring within the 10 mg/kg biweekly group (incidence ≥ 5% and extra frequent than within the placebo group) have been infusion reactions (19.9%), headache (13.7%), ARIA-E (9.9%), cough (8.7%), diarrhea (8.1%), dizziness (7.5%), microhemorrhages (5.6%).

Part III Readability AD examine was carried out as a placebo-controlled, double-blind, parallel-group, randomized examine of lecanemab 10 mg/kg or placebo administered bi-weekly for 18 months in 1,795 folks dwelling with early AD (152 of whom have been Japanese). Imply change of CDR-SB from baseline at 18 months as the first endpoint was 1.21 and 1.66 for lecanemab and placebo teams, respectively. Lecanemab therapy resulted in extremely statistically important outcomes, lowering scientific decline on the worldwide cognitive and purposeful scale, in contrast with placebo at 18 months by -0.45 (95% Confidence Interval (CI): -0.67, -0.23; P=0.00005), representing a 27% slowing of decline. Beginning as early as six months (distinction: -0.17 [95% CI: -0.29, -0.05]; P<0.01), and growing in absolute distinction over time throughout all time factors each 3 months, the therapy confirmed extremely statistically important modifications in CDR-SB from baseline in comparison with placebo (all p-values are lower than 0.01).

All key secondary endpoints, amyloid Positron Emission Tomography (PET) utilizing Centiloids, ADAS-Cog14, ADCOMS and ADCS MCI-ADL, additionally confirmed extremely statistically important outcomes in contrast with placebo (P<0.001).

The most typical antagonistic occasions (>10%) within the lecanemab group have been infusion reactions (lecanemab: 26.4%; placebo: 7.4%), ARIA-H (mixed cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis; lecanemab: 17.3%; placebo: 9.0%), ARIA-E (edema/effusion; lecanemab: 12.6%; placebo: 1.7%), headache (lecanemab: 11.1%; placebo: 8.1%), and fall (lecanemab: 10.4%; placebo: 9.6%). Infusion reactions have been largely mild-to-moderate (grade 1-2: 96%) and occurred on the primary dose (75%).

Through the examine interval, deaths occurred in 0.7% and 0.8% of individuals within the lecanemab and placebo teams, respectively and no deaths have been associated to lecanemab or occurred with amyloid-related imaging abnormalities (ARIA) in 18-month double-blind examine interval. Critical antagonistic occasions have been skilled by 14.0% of individuals within the lecanemab group and 11.3% of individuals within the placebo group. Remedy-emergent antagonistic occasions occurred in 88.9% and 81.9% of individuals within the lecanemab and placebo teams, respectively. Remedy-emergent antagonistic occasions resulting in drug withdrawal occurred in 6.9% and a pair of.9% of individuals within the lecanemab and placebo teams, respectively.

General, lecanemab’s ARIA incidence profile was inside expectations primarily based on the Part 2 trial outcomes. ARIA-E occasions have been largely mild-to-moderate radiographically (91% of those that had ARIA-E), asymptomatic (78% of those that had ARIA-E), occurred throughout the first 3 months of therapy (71% of those that had ARIA-E) and resolved inside 4 months of detection (81% of those that had ARIA-E). Among the many 2.8% of lecanemab-treated topics with symptomatic ARIA-E, essentially the most generally reported signs have been headache, visible disturbance, and confusion. The incidence of symptomatic ARIA-H was 0.7% within the lecanemab group and 0.2% within the placebo group. No imbalance was noticed in remoted ARIA-H (i.e., ARIA-H in individuals who didn’t additionally expertise ARIA-E) between lecanemab (8.9%) and placebo (7.8%).

4.  In regards to the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint growth and commercialization of AD therapies since 2014. Eisai serves because the lead of lecanemab growth and regulatory submissions globally with each corporations co-commercializing and co-promoting the product and Eisai having last decision-making authority.

5.  In regards to the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration relating to the event and commercialization of AD therapies. Eisai obtained the worldwide rights to check, develop, manufacture and market lecanemab for the therapy of AD pursuant to an settlement with BioArctic in December 2007. The event and commercialization settlement on the antibody lecanemab back-up was signed in Might 2015.

6.  About Eisai Co., Ltd.
Eisai’s Company Idea is “to present first thought to sufferers and folks within the day by day dwelling area, and to extend the advantages that well being care gives.” Beneath this Idea (often known as human well being care (hhc) Idea), we intention to successfully obtain social good within the type of relieving nervousness over well being and lowering well being disparities. With a worldwide community of R&D amenities, manufacturing websites and advertising subsidiaries, we attempt to create and ship progressive merchandise to focus on illnesses with excessive unmet medical wants, with a selected focus in our strategic areas of Neurology and Oncology.

As well as, we exhibit our dedication to the elimination of uncared for tropical illnesses (NTDs), which is a goal (3.3) of the United Nations Sustainable Improvement Targets (SDGs), with engaged on numerous actions along with international companions.

For extra details about Eisai, please go to www.eisai.com (for international headquarters: Eisai Co., Ltd.), and join with us on Twitter @Eisai_SDGs.

7.  About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide progressive therapies for folks dwelling with severe neurological illnesses in addition to associated therapeutic adjacencies. One of many world’s first international 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 the moment, Biogen has a number one portfolio of medicines to deal with a number of sclerosis, has launched the primary accredited therapy for spinal muscular atrophy, and developed the primary accredited therapy to handle a defining pathology of Alzheimer’s illness. Biogen can be commercializing biosimilars and specializing in advancing one of many business’s most diversified pipelines in neuroscience that can remodel the usual of look after sufferers in a number of areas of excessive unmet want.

We routinely put up data that could be vital to buyers on our web site at www.biogen.com. Comply with us on social media – Twitter, LinkedIn, Fb, YouTube.

¹ Protofibrils are giant Aβ aggregated soluble species of 75-500 Kd.
² CDR-SB is a numeric scale used to quantify the assorted severity of signs of dementia. Based mostly on interviews of individuals dwelling with AD and household/caregivers, certified healthcare professionals assess cognitive and purposeful efficiency in six areas: reminiscence, orientation, judgment and drawback fixing, group affairs, house and hobbies, and private care. The overall rating of the six areas is the rating of CDR-SB, and CDR-SB can be used as an applicable merchandise for evaluating the effectiveness of therapeutic medicine focusing on the early phases of AD.
³ ADCS MCI-ADL assesses the competence of sufferers with MCI in actions of day by day dwelling (ADLs), primarily based on 24 inquiries to the affected person’s companion about precise current actions of day by day dwelling.
⁴ ADCOMS is developed by Eisai, ADCOMS combines objects from the ADAS-Cog scale for assessing cognitive features, MMSE and the CDR scale for evaluating the severity of dementia to allow extremely delicate detection of modifications in scientific features of early AD signs and modifications in reminiscence
⁵ ADAS-Cog is the commonest cognitive evaluation instrument utilized in AD scientific trials all around the world. ADAS-Cog14 consists of 14 competencies: phrase recall, instructions, constructional praxis, object and finger naming, ideational praxis, orientation, phrase recognition, remembering phrase recognition directions, comprehension of spoken language, phrase discovering problem, spoken language skill, delayed phrase recall, quantity cancellation, and maze job. ADAS-Cog has been utilized in scientific trials for earlier phases of AD together with MCI.
⁶ An 80% or larger estimated chance of demonstrating 25% or larger slowing in scientific decline at 12 months therapy measured by ADCOMS from baseline in comparison with placebo.

Biogen Secure Harbor
This information launch accommodates forward-looking statements, together with statements made pursuant to the protected harbor provisions of the Non-public Securities Litigation Reform Act of 1995, concerning 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 therapy of Alzheimer’s illness; the anticipated advantages and potential of Biogen’s collaboration preparations with Eisai; the potential of Biogen’s business enterprise and pipeline packages, together with lecanemab; and dangers and uncertainties related to drug growth and commercialization. These statements could also be recognized by phrases resembling “intention,” “anticipate,” “consider,” “might,” “estimate,” “anticipate,” “forecast,” “intend,” “might,” “plan,” “attainable,” “potential,” “will,” “would” and different phrases and phrases of comparable that means. Drug growth and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and growth packages lead to commercialization of a product. Ends in early-stage scientific research is probably not 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 information 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 surprising issues which will come up from extra information, evaluation or outcomes obtained throughout scientific research, together with the Readability AD scientific trial and AHEAD 3-45 examine; the prevalence of antagonistic security occasions; dangers of surprising prices or delays; the chance of different surprising hurdles; regulatory submissions might take longer or be tougher to finish than anticipated; regulatory authorities might require extra 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 choices 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 information, mental property and different proprietary rights and uncertainties regarding mental property claims and challenges; product legal responsibility claims; third social gathering 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. Buyers ought to contemplate this cautionary assertion in addition to the chance elements recognized in Biogen’s most up-to-date annual or quarterly report and in different stories Biogen has filed with the U.S. Securities and Alternate Fee. These statements are primarily based on Biogen’s present beliefs and expectations and converse 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 on account of new data, future developments or in any other case.

View unique content material to obtain multimedia:https://www.prnewswire.com/news-releases/eisai-files-marketing-authorization-application-for-anti-amyloid-beta-protofibril-antibody-lecanemab-for-early-alzheimers-disease-in-japan-301721956.html

SOURCE Eisai Inc.