FDA accepts Biogen's application for Alzheimer's drug, decision due by March

Henrietta Strickland
August 9, 2020

Shares of Biogen jumped more than 11% in premarket trading after the company announced the U.S. Food and Drug Administration accepted its Biologics License Application for aducanumab, an investigational treatment for Alzheimer's disease.

Biogen Chief Executive Officer Michel Vounatsos said the FDA's acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer's disease.

Alzheimer's, the most common form of dementia, affects about 5.7 million Americans over the age of 65, and is expected to triple to almost 14 million by 2060, according to the U.S. Centers for Disease Control and Prevention. Biogen's stock is down 6.4% for the year, while the S&P 500 is up 3.6%. The regulator is expected to make a decision whether or not to approve aducanumab by March 7.

According to Biogen, the FDA "plans to act early" if possible on the application, and that an advisory committee will be scheduled so that outside experts can review the aducanumab data. The drug works by targeting the protein amyloid beta in the brain.

Scientist believe that these plaques are at least partially responsible for memory loss and cognitive decline in Alzheimer's patients.

Last year, Biogen stopped a pair of late-stage studies, concluding the drug demonstrated no benefit in patients with early-stage Alzheimer's.

Disappointment rippled through the Alzheimer's and scientific communities.

Wall Street analysts, however, remain divided about the data from the clinical studies.

Biogen said the FDA agreed to a shortened review schedule for the drug on its own, without requiring the company to cash in a priority review voucher that it owns. Stifel analyst Paul Matteis said the briefing documents released prior to the panel are expected to be "a bigger determinant than usual in dictating how panelists eventually vote" and called the panel the highlight of 2020 and 2021 for health-care investors. The agency is not required to follow the panel's recommendation, but often does.

"We largely view an advisory committee as one of the big 'clearing events" and predict it will be 'mixed, ' leaving the Street in limbo, ' Jefferies analyst Michael Yee said.

Other reports by Click Lancashire

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