CMS as gatekeeper: Why lecanemab is similar but also very different from Aduhelm
Both aducanumab and lecanemab — Eisai and Biogen’s Alzheimer’s drugs — are not only targeted at reducing the clumped beta-amyloid that has mystified and encouraged researchers for decades, using the same FDA accelerated approval pathway, and could also put a serious dent in Medicare’s budget.
Last night’s big unveiling of encouraging data for lecanemab — as clear a win as any in Alzheimer’s — also brought back memories of Aduhelm’s quick accelerated approval and tepid launch, thanks in a large part to CMS’ ultimate decision to require additional RCT data for the entire class of anti-amyloid mAbs.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.