Biogen (NASDAQ: BIIB) is facing its biggest moment ever. The U.S. Food and Drug Administration (FDA) will soon decide the fate of the company’s investigational Alzheimer’s drug. Investors and analysts consider the approval of aducanumab as critical to Biogen’s future growth. Why? Because generic competition is eroding Biogen’s billion-dollar multiple sclerosis business.
The biotech giant needs a new blockbuster product. And aducanumab — if approved — would surely be it. More than 5 million Americans suffer from Alzheimer’s, according to The Alzheimer’s Association. Now you might say: Well, if clinical trial results were positive, aducanumab has a good shot at approval, right? The problem is that the data haven’t convinced everyone — including an FDA advisory committee.