FDA approval of Alzheimer's drug Aduhelm ‘rife with irregularities’
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This comes against the backdrop of criticism as the FDA is expected to decide on approving another drug for treating the disease in January.
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Probe: Alzheimer’s drug approval ‘rife with irregularities’
Sources reported on Friday that the 2021 FDA's approval of an Alzheimer's drug called Aduhelm was "rife with irregularities" as an 18-month congressional investigation issued on Thursday found an "atypical collaboration" between FDA regulators and Aduhelm manufacturer, Biogen.
According to the probe, investigators found that the company intended to "make history" when it set an "unjustifiably high" initial yearly price of $56,000 for the drug.
This comes against the backdrop of criticism as the FDA is expected to decide on approving another drug for treating the disease in January.
The report also found that there was an unusually high amount of phone exchanges between company officials and FDA delegates.
It also revealed that the company and the agency spent months preparing a report that did not account for substantial disagreement within the FDA about how to handle Aduhelm.
The report called on the agency to take "swift action" to make sure that any future approvals aren't met with "the same doubts about the integrity of FDA’s review."
Both the company and the FDA issued statements on Thursday to defend Aduhelm's approval process.
Biogen knew Aduhelm would dramatically affect Medicare. If just 250,000 patients got the drug, it would account for more than 25% of the Part B budget. If Aduhelm reached its full potential, it would cost taxpayers upward of $70 billion. pic.twitter.com/B2y46UrE95
— Damian Garde (@damiangarde) December 29, 2022
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The FDA approved Aduhelm in 2021 under accelerated approval over the objections of its independent scientific advisors who felt the data failed to prove the drug's benefit to patients.
The company had reportedly halted two studies after results suggested that the drug wasn't giving the desired effects: slowing Alzheimer's deteriorating process.
The FDA said the drug was efficient on the grounds that it reduced a buildup of plaque in the brain.
But three of the agency's advisors resigned in protest of these claims and the agency's then-acting chief was called for questioning.
Medicare eventually declined to fund the drug, even after the yearly price was reduced to $28,000.
In a statement Thursday, FDA said its "decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials. ... That said, the agency has already started implementing changes consistent with the Committee's recommendations."
On Biogen's part, it said "Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm,” but that it “stands by the integrity of the actions we have taken."
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