Biogen headquarters in Cambridge, Massachusetts, on October 24, 2023.
vanessa leroy | Bloomberg | fake images
biogen on Wednesday said it will discontinue the sale and development of its long-standing and highly controversial Alzheimer's drug, Aduhelm, to refocus the company's efforts to treat the memory-robbing disease.
The biotech company will focus on the launch of Leqembi, a recently approved Alzheimer's drug it developed with the Japanese manufacturer. Eisai. He also plans to work on a series of experimental treatments for the disease. Those drugs represent a new chapter for the company after the polarizing launch and approval of Aduhelm.
The U.S. Food and Drug Administration gave the green light to Aduhelm in 2021 under a program that accelerates promising treatments. But the decision was surrounded by controversy, as some experts had doubts about whether the drug's benefits outweighed its risks.
The federal Medicare program severely restricted access to Aduhelm, limiting its sales potential, and an 18-month congressional investigation would later allege that the FDA's approval process for the drug was “riddled with irregularities.”
But Biogen said Wednesday that its decision to abandon Aduhelm “was not related to any safety or efficacy concerns.”
The company said it will suspend sales of the drug and has taken a one-time charge of $60 million to end the Aduhelm program in the fourth quarter.
Neurimmune, the Swiss company that invented the drug, will regain all rights to the drug, according to Biogen.
Biogen is also ending a post-approval clinical trial of Aduhelm after failing to find a partner or outside funding for the drug. That study sought to demonstrate the benefits of the treatment for patients in the early stages of Alzheimer's disease.
The company said it will redeploy a large portion of the resources associated with Aduhelm to the rest of its Alzheimer's drug portfolio.
Among the other Alzheimer's drugs Biogen has in development is BIIB080, which targets a toxic protein called tau in the brain. That treatment has shown “favorable trends” on several measures of cognition and function in a small study.
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