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Aducanumab Approval

The US Food and Drug Administration has approved the Alzheimer's disease treatment aducanumab, NPR reports. It adds that this is the first approval of an Alzheimer's disease treatment in 18 years.

But whether aducanumab works is unclear, NPR adds. Biogen, the drug's maker, terminated trials of the drug in patients after an early analysis suggested it was not working as hoped. But as Time magazine reported in 2019, the company decided to seek FDA approval for the drug following a re-analysis that suggested one trial showed a slowing of cognitive decline among some Alzheimer's disease patients. Regulators at FDA appeared to support the approval, as Stat News reported last November, but an outside advisory panel was less certain that the drug was effective and additionally seemed perturbed that FDA asked it to focus on the positive study, as NPR reported then.

NPR now reports that FDA approved aducanumab, which is to be marketed by Biogen as Aduhelm, under its accelerated approval pathway and with the stipulation that Biogen conduct another clinical trial. The Washington Post reported last week that some critics were calling for another trial prior to FDA approval.

As Science adds, the FDA usually accepts the recommendations of its outside panel of advisors, and some critics sees this approval as a weakening of standards at the agency. Others have lauded the approval and say it will spark further investment in Alzheimer's disease therapies.