An advisory panel to the US Food and Drug Administration has determined there isn't enough data to gauge whether an Alzheimer's disease drug under investigation works, NPR reports.
Biogen had shelved its aducanumab treatment targeting the accumulation of amyloid protein in the brains of individuals with Alzheimer's disease, but, as Time magazine reported last year, the company later resurrected the drug after a re-analysis of its data suggested that it might have an effect on cognitive decline after all. A recent review of the data by the FDA indicated that the agency might be in agreement with Biogen's finding that patients might benefit from treatment with aducanumab, as Stat News reported last week.
But the advisory panel that met Friday was less sure, according to NPR. It notes that one aducanumab study suggested it worked and another study indicated it did not, but that the FDA asked the panel to focus on the positive one. This, it adds, did not seem to go over well with the panel, which rejected the idea of approving the drug. FDA generally follows the recommendations of its advisory panels.
"Alzheimer's treatment is a huge, urgent, unmet need, but I also think if we approve something where the data is not strong, we have a risk of delaying good treatment," Joel Perlmutter from Washington University in St. Louis, one of the panel members, tells Science.