Third FDA panel member quits over controversial Alzheimer’s drug approval

pharmafile | June 11, 2021 | News story | Medical Communications  

The third FDA advisory panel member has quit over the approval of a controversial new Alzheimer’s drug.

Biogen’s drug, aducanumab, was the first new Alzheimer’s drug to be approved in nearly two decades, but there is much debate over whether the drug actually works.

In a resignation letter obtained by CNBC, Dr Aaron Kesselheim, a Professor of Medicine at Harvard Medical School, said the agency’s decision to approve Biogen’s drug, “was probably the worst drug approval decision in recent US history.”

All 11 members of the advisory committee voted against approving aducanumab, though the FDA is not required to follow the committee’s advice, it usually does.

Dr Aaron Kesselheim said in an email, “My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees…because I didn´t think that the firm recommendations from the committee in this case…were appropriately integrated into the decision-making process.

“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system.”

Dr Joel Perlmutter and Dr David Knopman also resigned after the FDA ignored their warnings that aducanumab had not actually demonstrated any slowing in the disease.

The FDA said they approved the drug after deciding that it could manage some symptoms of Alzheimer’s, including anxiety and insomnia, saying the approval is “based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients”.

Dr David Knopman, a neurologist at the Mayo Clinic, told Insider, “The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That’s what their press release said in so many words.

“That seems illogical to me. I don’t want to be a part of that in the future.”

Aducanumab targets the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms.

The WHO estimates that 50 million people around the world suffer with dementia, with Alzheimer’s contributing up to 70% of those cases. 10 million new cases are added every year.

Lilly Subbotin

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