The fallout from the FDA’s recent decision to grant Biogen’s Alzheimer’s drug-accelerated approval has seen two advisory panel members resign. The agency’s decision, which was met with mixed reviews and marked the first approval of an Alzheimer’s drug in almost two decades, came after the Peripheral and Central Nervous System Advisory Committee said in November that it was unreasonable to consider the clinical benefit of the drug. based on a successful study.
One of the members who resigned, Dr. David Knopman, is a neurologist from the Mayo Clinic who, according to Reuters, had been recalled from the November meeting because he was an investigator in Biogen̵
“I was very disappointed with the way the Advisory Committee’s input was handled by the FDA,” Knopman told the outlet. “I do not want to be put in a position like this again.”
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The other member is Dr. Joel Perlmutter, a neurologist at Washington University in St. Louis, who told STAT that his resignation on Monday was due to “this decision by the FDA without further discussion with our advisory committee.”
In a statement regarding Biogen’s approval, Dr. Patrizia Cavazzoni, FDA Center for Drug Evaluation and Research Director, said that when the panel said there was not enough data to consider the benefit of the drug, it had not discussed the possibility of Accelerated Approval in November. Accelerated Approval allows drugs targeted at serious conditions that meet an unmet medical need to be approved “based on a surrogate endpoint”, which is a marker that is assumed to predict clinical benefit but is not in itself a target for clinical benefit.
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However, according to STAT, panelists were not asked to consider this option as the committee had decided they would not use the amyloid “as a surrogate for effectiveness.”
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“After the advisory committee provided feedback, our review and discussions continued, and we decided that the evidence presented in the Aduhelm application met the standard of accelerated approval,” Cavazzoni said. “We thank the Advisory Committee for its independent review of the data and valuable advice.”
The FDA does not have a mandate to follow the advice of the advisory committee, but often makes decisions based on their recommendations.
The agency’s decision was celebrated by others, including the Alzheimer’s Association, who called the approval “the beginning of a whole new future for Alzheimer’s treatments.”