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Closure on Biogen's Aduhelm Launch - Congressional Report

Two US House of Representatives' committees undertook an 18-months long investigation into what occurred in the F.D.A's 'accelerated approval' of Biogen's new medication to treat early stage Alzheimer's disease. The drug, marketed as Aduhelm, was approved for use by patients demonstrating sufficient amyloid buildup to qualify as having early stage Alzheimer's. At the time of its approval, Biogen was providing the drug at a price of $56,000 a year (later dropped to $28,800). Many experts criticized the F.D.A for its approval, noting it premature as the drug was not sufficiently vetted for mitigating the behavior affects of Alzheimer's dementia. The committee's report noted that the F.D.A. neglected to follow many of its internal procedures in offering accelerated approval against the advice of its expert panel. Other scientists noted that the drug had been insufficiently tested and called for its limited application. Noteworthy was the report's criticism that the clinical trials were insufficiently inclusive with respect to the trial's participants. The intellectual disability community raised concerns that adults with Down syndrome were excluded from the trials and that there were insufficient data on its safety and efficacy for use with this group. For detailed information on the House report, see 'Congressional Inquiry Faults F.D.A. and Biogen in Aduhelm Approval' (New York Times, December 30, 2022, p. A16).


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