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Closing The Books On Aduhelm: Congressional Report Leaves US FDA To Move Forward

 
• By Michael McCaughan

A Congressional report on the US FDA approval of Biogen/Eisai’s Aduhelm generated another round of negative headlines for the agency – and rubbed salt in the wounds of a commercial disaster for the sponsors. But it probably could not have turned out better for FDA and the drug review climate overall.

closing the book on Aduhelm
The House report on Aduhelm is probably headed straight for the shelf. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, House report images

It is hard to imagine a quieter end to the House Energy & Commerce Committee’s investigation into the US Food & Drug Administration’s handling of the review of Biogen, Inc./Eisai Co., Ltd.’s Alzheimer’s therapy Aduhelm (aducanumab-avwa).

The Congressional inquiry was launched with much fanfare two weeks after Aduhelm was approved in June 2021, amid headlines warning of the potential for the new therapy to bankrupt the Medicare program and noting the protests of FDA’s own expert advisors who staunchly opposed approval in the first place

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