FDA approved Aduhelm earlier this month, despite advisory committee’s conclusion that there was not enough evidence to support its effectiveness
THURSDAY, July 1, 2021 (HealthDay News) — The U.S. Food and Drug Administration’s controversial approval of a new drug for Alzheimer disease, along with its high price, is now being investigated by two House committees.
“We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,” House Democrats Carolyn Maloney and Frank Pallone Jr. said in a statement from the Committee on Oversight and Reform and the Committee on Energy and Commerce, CNN reported. “We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer’s disease, but Aduhelm’s approval and its $56,000 annual price tag will have broader implications for seniors, providers, and taxpayers that warrant close examination.”
Although an FDA advisory committee concluded there was not enough evidence to support the effectiveness of Aduhelm (aducanumab), the agency went ahead and approved the drug earlier this month, CNN reported. Three of the advisory committee members resigned after the FDA approved the drug.
Most of the reviewers at the FDA who assessed the company’s submissions for aducanumab did recommend approval, CNN reported. “Alzheimer’s disease is a serious condition and aducanumab, unlike other approved therapies, is targeted at an underlying, fundamental, and defining pathophysiological feature of the disease, with the potential to alter the inescapable and relentless progression of this disease,” the reviewers said.
The drug is infused once every four weeks. The wholesale cost is about $4,312 per infusion.
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