Lilly awaits donanemab’s big day at the FDA

The US Food and Drug Administration (FDA) is to hold an advisory committee meeting on Monday (June 10) to discuss whether data support a favorable benefit-risk assessment for the use of Eli Lilly’s (NYSE: LLY) donanemab for Alzheimer’s disease (AD).

If approved, donanemab would become the third amyloid-targeting therapy to win approval from the FDA, following on from the Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) products Aduhelm (aducanumab) and Leqembi (lecanemab), albeit that the former has been withdrawn from the market amid poor sales and doubts over the supporting data.

Lilly originally submitted an application for accelerated approval of donanemab based on amyloid plaque reduction in Phase II study AACG.