FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy
By Editor - Fri Jun 04, 5:12 am
The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process. This story also ran on The Daily Beast . It can be republished for free. The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment , stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.