In This Article:
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD, collectively known as early AD, in the EU.
Please note that, in November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending marketing approval for Leqembi for early AD.
Biogen and Eisai announced that the European Commission (EC) has requested the CHMP to reassess new safety data that emerged after the positive opinion and determine if any updates are needed. Additionally, the CHMP will review the clarity of risk minimization measures in its opinion to ensure proper implementation. These discussions are scheduled for an upcoming CHMP meeting later this month.
Biogen and Eisai stated that the safety profile of lecanemab observed in clinical studies across the United States, Japan and other countries aligns with its approved labels, with no new safety concerns identified. Given the clarity and sufficiency of the available information, the companies believe that existing data will address the EC’s requests, which the CHMP will review.
BIIB stock lost 1.6% on Friday following the news. Shares of Biogen have plunged 17.1% in the past three months compared with the industry’s decline of 6.5%.
Image Source: Zacks Investment Research
We remind the investors that the CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July 2024.
The negative opinion was reportedly due to a brain swelling side effect called amyloid-related imaging abnormalities associated with the use of anti-amyloid therapies like Leqembi. Eisai requested the CHMP to re-examine its opinion back then.
BIIB, Eisai's Leqembi Approved in Other Countries
Leqembi gained full approval from the FDA for early AD in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services in July 2023. The drug is also approved in China, Japan, Israel, Hong Kong, South Korea, the UAE and Great Britain.
Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
Other Updates on BIIB & Eisai's Leqembi
Recently, Biogen announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered AD drug, Leqembi. Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug. Alternatively, patients can also opt to continue with the biweekly dosing regimen. The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming — nearly one hour for each infusion.