Biogen’s Alzheimer’s Drug is in the Home Stretch, but Can it Win Approval?
The journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether the U.S. Food and Drug Administration (FDA) reject it or give approval, remains to be seen. But the target action date for the agency’s decision is June 7.
If approved, aducanumab would be the first-ever drug to slow the progression of Alzheimer’s and first-ever drug to treat mild cognitive impairment. Early-stage Alzheimer’s has not been afforded a new approved therapy in more than 17 years. No other major disease of Alzheimer’s scale and mortality has gone that long without incremental therapeutic relief.