FDA in precarious situation with Biogen’s Alzheimer’s drug

An FDA advisory panel have delivered a crushing blow to Biogen’s experimental Alzheimer’s treatment, aducanumab. Last week, 10 of the 11 members of the committee of outside experts voted against approval of the drug (one member abstained from voting), citing a lack of convincing evidence that the drug is effective. 

The verdict wasn’t necessarily a surprise. In late October, RBC Capital Markets, an analytical firm, put together a mock advisory committee who voted 6-2 against recommending approval. 

But the FDA put itself in a tough spot by publishing pre-meeting documents ahead of its own advisory meeting which reflected positive views of the drug and seemed geared towards setting the stage for approval. 

It’s been 17 years since the agency reviewed a new treatment for Alzheimer’s and the market is clearly hungry for new options. If approved, aducanumab would likely become a blockbuster for Biogen.

Yet, if the FDA acts against the recommendations of its panel — which it rarely does — it could harm the agency’s and the pharma industry’s reputation at a time when public trust in new treatments, such as COVID-19 vaccines, is crucial.

The FDA is expected to make the final call on aducanumab by March.   

Biogen’s shares plummeted 30 percent on Monday.