The FDA's approval process of Alzheimer’s drug Aduhelm has been deemed “rife with irregularities,” according to a congressional investigation. Here are takeaways from the report.
Documents show"the agency’s review and approval process for Aduhelm was highly atypical and deviated from FDA’s guidance and procedures in significant respects,” the report by the House Oversight and Reform and Energy and Commerce committees reads.According to the House report:
The FDA approved the label, which was a “far broader” population than the company studied in its clinical trials. Cost was also significant part of the public backlash following the drug’s launch. The report said the price for Aduhelm – $56,000 per year – was “unjustifiably high,” and that Biogen tried to “make history” for the company despite lack of clinical benefit. The company said it wanted to “establish Aduhelm as one of the top pharmaceutical launches of all time.”
In statements released Thursday, the company and its regulator defended the process, but the FDA said it is “already starting” to implement changes recommended by the committees, according to aWhat's next: FDA set to review another Alzheimer's drug in January
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