Biogen’s Next Alzheimer Drug Feeds Push for FDA Approval Revamp

Promising trial results on Eisai Co. and Biogen Inc.‘s Alzheimer’s drug don’t discount the need for changes to the fast-track approval pathway the FDA is using to review the product, doctors and health policy analysts say.

The companies said this week their experimental lecanemab significantly slowed the progression of Alzheimer’s disease among participants in a global Phase 3 confirmatory trial. They said they plan to use the findings in an application for full approval in the US by March 2023, as they await a decision on accelerated approval.

Lawmakers are pushing for changes to the accelerated approval pathway amid ...