Alzheimer's ad­comm mem­bers ques­tion FDA: How can you use amy­loid as the ba­sis for an ac­cel­er­at­ed ap­proval?

The FDA has not yet pro­vid­ed a per­sua­sive sci­en­tif­ic ba­sis for de­clar­ing be­ta-amy­loid as a rea­son­able sur­ro­gate for an ac­cel­er­at­ed ap­proval, sev­en mem­bers of the ad­comm that re­viewed ad­u­canum­ab and unan­i­mous­ly vot­ed against its ap­proval, wrote Wednes­day in the New Eng­land Jour­nal of Med­i­cine.

Al­though the FDA has re­leased key re­views on the in­ter­nal dis­sent around the agency’s de­ci­sion to OK Bio­gen’s new con­tro­ver­sial Alzheimer’s drug, the ex­perts (three of whom have since re­signed from the ad­comm in protest over the ap­proval) ex­plained how more than two dozen ther­a­pies based on this amy­loid hy­poth­e­sis have un­der­gone late-stage clin­i­cal tri­als, and none have shown mean­ing­ful clin­i­cal ben­e­fit.

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