A group of medical professors and expert researchers in Alzheimer's disease have asked the FDA to quickly withdraw their approval of Aduhelm. The recommendation comes after months of controversy surrounding Biogen's expensive Alzheimer's disease treatment. Several outside experts have pilloried the agency for the drug's approval despite a lack of clear evidence of clinical improvement and exorbitant price range. This has made the drug a no-go for many payers.
According to an Endpoints News article, the group of researchers wrote, “In two prematurely terminated trials, one showed no effect, while the other showed an effect that was not clinically meaningful. The FDA's decision to approve Aduhelm is indefensible in both scientific and clinical terms. This drug should be withdrawn from the market immediately.”
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(Source: EndpointsNews, December 21st, 2021)