FDA panel declines to endorse controversial Alzheimer drug

Hopes for a new Alzheimer disease (AD) treatment were dashed on Friday, when an FDA advisory panel concurred that the evidence for aducanumab (Biogen) was not compelling enough to win their backing. Ten of 11 panel members found that research presented during the 7-hour virtual meeting was not strong enough to support a push for the monoclonal antibody, which was being eyed as the first new AD therapy in nearly 20 years. The vote delivered an unexpected blow, considering that FDA had released documents just 2 days earlier indicating that most of its clinical reviewers thought the evidence convincing. The committee’s recommendation is nonbinding and does not necessarily mean FDA will reject the drug, which targets patients in the early stages of AD when cognitive effects are still mild. A major sticking point for the advisory committee centered around clinical trials of aducanumab, one of which generated favorable results and one of which did not. Many of the experts sitting on the panel suggested that rather than accepting the results of one study over the other, a third rigorous trial is needed before deciding the fate of the drug.