STAT+: Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say
If ever there were a cautionary tale for the Food and Drug Administration’s approval of the Alzheimer’s drug Aduhelm, it might be in the 2016 approval of Exondys 51.
In signing off on the drug, the FDA bucked the recommendation of an independent advisory committee and issued a landmark accelerated approval for the drug, which is aimed at a devastating childhood disease called Duchenne muscular dystrophy.
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