.HouseDemocrats fault US_FDA's 'atypical' review process for Biogen's Alzheimer's drug
The Food and Drug Administration's approval process for Biogen's controversial Alzheimer’s drug was"rife with irregularities," a report from House Democrats concluded.
Biogen's Aduhelm became the first new therapy for Alzheimer's in nearly two decades to receive approval last year, despite the FDA's advisory committee voting against approving the drug. It has since faced challenges on the market with an initial price tag of $56,000 annually, which Biogen later cut, and Medicare significantly limiting coverage of the drug.
"FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review," the report concluded.
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