Eisai and Biogen's Lecanemab Receives FDA Priority Review for Full Approval in Alzheimer’s Disease

On March 6, Eisai and Biogen jointly announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for lecanemab (brand name: Leqembi) and granted it Priority Review to convert the accelerated approval of lecanemab for the treatment of Alzheimer's disease (AD) into a full approval. The PDUFA date is July 6, 2023. The FDA plans to hold an advisory committee meeting to discuss this application, but the specific meeting date has not yet been announced.

Lecanemab is an anti-amyloid beta (Aβ) monoclonal antibody that selectively neutralizes and eliminates soluble and toxic Aβ aggregates, which cause Alzheimer's disease neuropathy. Therefore, lecanemab may positively impact the AD pathological process and slow disease progression. Eisai and Biogen jointly oversee the development and commercialization of the product, with Eisai retaining final decision-making authority.

On January 6, based on the results of the Phase IIb proof-of-concept clinical trial (BAN2401-G000-201), the FDA approved the marketing application for lecanemab for the treatment of AD under the accelerated approval pathway. However, lecanemab treatment can only be administered to AD patients in the mild cognitive impairment or mild dementia stage who are pathologically confirmed to have Aβ.

On the same day that lecanemab received accelerated approval, Eisai submitted an sBLA to the FDA seeking full approval for lecanemab. This application is based on the positive results of the confirmatory Phase III Clarity AD study, which met its primary endpoint and all key secondary endpoints, with results showing high statistical significance.

Currently, the pricing for lecanemab is $26,500 per year. The U.S. Centers for Medicare & Medicaid Services (CMS) has previously indicated that it might consider expanding coverage when lecanemab receives full approval.

It is worth mentioning that the marketing application of lecanemab in China was accepted by the CDE in December 2022.

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