A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy.
The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.
STAT News reported yesterday that Joel Perlmutter, a neurologist at Washington University (St. Louis) and a member of the FDA’s expert panel for nervous system therapies, told the outlet that he quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.”
In March, three FDA advisory committee members — none of them Perlmutter — published an editorial in JAMA expressing reservations about aducanumab’s clinical trial data. The FDA’s approval of the drug is conditional, with Biogen required to run a confirmatory clinical trial for the drug, while some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective.
The drug’s price tag plays a significant role as it totals approximately $50,000 annually, which may limit support from payers. GlobalData still projects that aducanumab will rake in $5.5 billion internationally by 2027.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Neurological Disease