Story at a glance
- The Food and Drug Administration’s approval of a new Alzheimer’s drug has prompted the resignation of two members of an outside advisory board to the agency.
- Mayo Clinic neurologist David Knopman, a member of an 11-person panel that agreed unanimously that the agency should not approve Biogen’s Aduhelm Alzheimer’s treatment, resigned Wednesday.
- Washington University neurologist Joel Perlmutter also tendered his resignation Tuesday.
The Food and Drug Administration’s (FDA) approval of a new Alzheimer’s drug has prompted the resignation of two members of an outside advisory board to the agency.
Mayo Clinic neurologist David Knopman, a member of an 11-person panel that agreed unanimously that the FDA should not approve Biogen’s Aduhelm Alzheimer’s treatment, resigned Wednesday, Reuters reported. Washington University neurologist Joel Perlmutter tendered his resignation Tuesday.
“I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters. “I don’t wish to be put in a position like this again.”
Reuters reported that the panel found inconclusive evidence regarding the drug’s efficacy. The FDA granted the Aduhelm “accelerated approval” on Monday due to its belief that the drug could combat a contributor to the disease, according to the outlet. Aduhelm is the first Alzheimer’s drug to receive FDA approval since 2003.
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Biogen will need to submit its drug to further trials to prove its benefits, and the FDA could still take it off the market should evidence counter reasons for the approval.
“Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials,” an FDA statement said.“If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.”
“There has been considerable public debate on whether Aduhelm should be approved,” the FDA continued. “As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.”
Yet the new drug comes with an annual price tag near $56,000. Biogen CEO Michel Vounatsos told CNBC on Monday that he believes the cost is “fair,” citing a decades-long dearth of innovation and the overall price Americans pay for Alzheimer’s and dementia related illness every year. Vounatsos added that the price would not rise over the next four years.
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Published on Jun 10,2021