A Biogen facility in Cambridge, Massachusetts, the US, March 9 2020. Picture: REUTERS/BRIAN SNYDER
Aduhelm, however, is in a different league in terms of the number of potential patients and cost to the healthcare system. The FDA approval allows Biogen to sell its product over several years — with forecasts for potential annual sales reaching as high $10bn to $50bn — until the company completes a required follow-up study.
“I believe they came to the right decision on behalf of the American public,” Sandrock said in an interview.The FDA has defended its decision by saying that Biogen presented clear evidence that Aduhelm, known chemically as aducanumab, removed beta amyloid from the brains of people with Alzheimer’s. “We can't say right now whether this will be a path for other Alzheimer's drugs, or drugs for other neurodegenerative diseases,” Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, told Reuters.“We need to rethink the use of these regulations as interpreted and used by FDA,” said Karlawish.
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