Aduhelm Approval Prompts Discussions on Reforming the FDA’s Accelerated Approval Pathway

The Food and Drug Administration (FDA)’s contentious approval of Biogen’s Aduhelm has prompted discussions on how the accelerated approval process could be reformed. The FDA’s Rick Pazdur expressed concern while a recent article co-authored by the Institute for Clinical and Economic Review (ICER)’s President Steven Pearson lists nearly a dozen proposed changes to the accelerated approval pathway.

“On surrogate endpoints, the researchers call for FDA to release for public comment a preliminary justification for why such an endpoint could be used, including what criteria FDA has already established to support that endpoint. The public comment period could allow clinical experts and other stakeholders with expertise in a particular area to see the FDA’s thinking and contribute to the final decision on using that endpoint.” Read more here.

(Source: Zachary Brennan, Endpoints News, 8/25/21)