Biogen Alzheimer's Drug Seeks FDA Approval After 'Highly Persuasive' Trial

A drug developed by Biogen (BIIB) to treat Alzheimer’s disease is on track to be approved by the Food and Drug Administration after a “highly persuasive” clinical trial, according to reports Wednesday. The drug, which is called aducanumab, is intended to slow cognitive decline for those in the early stages of the disease and would be the first such drug to be approved by the FDA.

Aducanumab has completed a late-stage trial that the FDA's advisory committee says is “capable of providing the primary contribution to a demonstration of substantial evidence of the effectiveness of Aducanumab."

The news is a surprising departure from results in 2019, when a trial analyzed by an independent group indicated that the drug was not effective. In October, Biogen announced it was seeking regulatory approval after a reanalysis of the data.

Biogen says its results show a marked slowing of clinical decline among patients in the early stages of Alzheimer’s who are given aducanumab. The trial also indicated that the drug performed well on safety metrics.

The FDA will address Biogen's drug on Friday.

"On November 6, 2020, the committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease," the FDA's advisory committee reads on the agency's official website.

Alzheimer’s is the sixth-leading cause of death in the U.S. There are no approved drugs to treat the disease.

Shares of Biogen surge 42% on Wednesday on news of aducanumab.

Aducanumab will go before an independent panel of experts who will recommend whether or not the FDA should approve the drug. The FDA’s final decision is expected by March.