STAT Plus: With high stakes, eight experts would wield extraordinary influence on fate of Biogen’s Alzheimer’s drug
After 17 years of hope and frustration, the decision over whether to approve, at last, a new treatment for Alzheimer’s disease could come down to eight people sitting in a suburban hotel ballroom.
Biogen is planning to seek Food and Drug Administration approval for a once-disregarded drug, and if everything goes according to plan, the company will have a date with the agency’s Peripheral and Central Nervous System Drugs Advisory Committee. That revolving group of outside experts is one of about 50 committees tasked with voting on whether the FDA should approve a product. The results aren’t binding, but experts’ opinions can sway how regulators rule on controversial applications.
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