NEC member Biogen Inc. has earned approval from the U.S. Food and Drug Administration (FDA) for Aduhelm, a drug to treat early-onset Alzheimer’s disease.
The drug has been given the green light through the FDA’s accelerated approval pathway, meaning the agency acknowledges that there is “some uncertainty” but believes it still could provide clinical benefits — and that those benefits ultimately outweigh the risks. However, the FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit, and could remove it from the market if future data warrants it.
“This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease,” CEO Michel Vounatsos said in the statement. “We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.”
The New England Council commends Biogen for their vigorous work in the fight against Alzheimer’s disease. Read more from the Boston Business Journal.
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