Controversial Alzheimer’s Drug Takes Step Toward FDA Approval

Biogen Inc.’s experimental Alzheimer’s disease treatment aducanumab was granted priority review status by U.S. regulators, a move that could hasten the drug’s arrival on the market.

The company said in astatement Friday that the Food and Drug Administration had granted its application with an action date of March 7, though it said the agency could act earlier under an expedited review.

Shares of the Cambridge, Massachusetts-based biotechnology company climbed by 12% in premarket trading on Friday.

The priority review had been sought by Biogen and its Japan-based partner Eisai Co. when the companies submitted their application for approval of aducanumabearlier this month. RBC Capital Markets analyst Brian Abrahams said the designation may offer positive signals toward a potential approval.

Aducanumab, a so-called monoclonal antibody designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for years. Biogen at one point halted research on it after getting disappointing results, only to revive the drug in a reversal that surprised scientists and investors and raised the hopes of patients and families.

The drug and the stop-start study process have been viewed skeptically by some. Data presented in December at the Clinical Trials on Alzheimer’s Disease conference in San Diego showed conflicting findings, with one trial suggesting the drug could be the first-ever to slow the progression of Alzheimer’s. But a second, essentially identical trial showed no effect on the disease at all.

Alzheimer’s is a progressive disease that most commonly arises in people over age 60. It robs patients of their memories and their minds, causing impaired speech and thought. More than 5 million Americans are living with the disease, according to themost recent data from the U.S. Centers for Disease Control and Prevention, and more than 14 million are expected to suffer from it by 2060.

With no medications currently available to slow the progression of the disease, demand for a therapy like aducanumab would be substantial.

The next focus for investors will be a meeting of outside advisers to review the results generated by Biogen. 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.

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