A scorchingly positive adcom was somewhat unexpected given the FDA’s scepticism in the briefing documents.
In an unprecedented situation Biogen sought to restrict the use of Aduhelm weeks after the drug’s approval. And the FDA said yes.
Dolutegravir’s patent expiry will pile on the pressure as Gilead and Merck get on the long-acting bandwagon.
Biogen’s Aduhelm was the big one, but there are plenty of other key regulatory decisions still pending this year.