The Biogen headquarters in Cambridge, Massachusetts, on Oct. 24, 2023.
Vanessa Leroy | Bloomberg | Getty Images
Biogen on Wednesday said it will discontinue the sale and development of its older 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 rolling out Leqembi, a newly approved Alzheimer’s drug it developed with Japanese drugmaker Eisai. It also plans to work on a slate 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 greenlit Aduhelm in 2021 under a program that fast-tracks promising treatments. But controversy shrouded the decision as some experts had concerns about whether the benefits of the drug 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 “rife with irregularities.”
But Biogen noted on Wednesday that its decision to drop Aduhelm was “not related to any safety or efficacy concerns.”
The company said it will discontinue sales of the drug and has taken a one-time charge of $60 million for ending the Aduhelm program in the fourth quarter.
Neurimmune, the Swiss company that invented the drug, will regain full rights to the medicine, according to Biogen.
Biogen is also terminating a post-approval clinical trial on Aduhelm after failing to find a partner or external financing for the drug. That study sought to prove the treatment’s benefits for patients in the early stages of Alzheimer’s disease.
The company said it will redistribute 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” across several measures of cognition and function in a small study.
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