Despite doubts, drugmakers double down on anti-amyloid approach

Setting aside  trouble gaining market access for the newly-approved Aduhelm (aducanumab), Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) continue to pursue early registration of their next-generation Alzheimer’s med.

Based on discussions with Japan’s Ministry of Health, Labor and Welfare (MHLW), Eisai has been granted permission to use the “prior assessment consultation” process for lecanemab, with the goal of shortening the review period.

The additional data of the application package will now be submitted, with primary endpoint data from the key Clarity AD study expected later in 2022.