The FDA Unhappy With Biogen’s 9-Year Postmarket Timeline, Asks For Prompt Aduhelm Data

The Food and Drug Administration (FDA)’s approval of Biogen’s Aduhelm is facing widespread criticism, especially after an undisclosed pre-approval meeting came to light. Now, the FDA has asked that Biogen speed up its postmarket timeline for the Alzheimer’s disease drug.

“A week after granting Accelerated Approval to Biogen’s controversial Alzheimer’s drug, FDA leaders met with company officials and asked them to commit to speeding up collection of postmarket data. Biogen initially said its postmarket study would be done by 2030, exasperating one FDA adviser who said nine years is too long to wait. Now, the company says it hopes to complete the trial earlier.” Read more here.

(Source: Beth Wang, Inside Health Policy, 7/6/21)