The Biogen headquarters in Cambridge, Massachusetts, on Oct. 24, 2023.
Vanessa Leroy | Bloomberg | Getty Images
Biogen on Wednesday said it would discontinue the sale and development of its older and highly controversial Alzheimer’s drug Aduhelm to refocus the corporate’s efforts to treat the memory-robbing disease.Â
The biotech company will deal with 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 recent chapter for the corporate after the polarizing launch and approval of Aduhelm.Â
The U.S. Food and Drug Administration greenlit Aduhelm in 2021 under a program that fast-tracks promising treatments. But controversy shrouded the choice as some experts had concerns about whether the advantages 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.”Â
But Biogen noted on Wednesday that its decision to drop Aduhelm was “not related to any safety or efficacy concerns.”
The corporate said it would discontinue sales of the drug and has taken a one-time charge of $60 million for ending the Aduhelm program within the fourth quarter.Â
Neurimmune, the Swiss company that invented the drug, will regain full rights to the drugs, in line with Biogen.
Biogen can also be terminating a post-approval clinical trial on Aduhelm after failing to search out a partner or external financing for the drug. That study sought to prove the treatment’s advantages for patients within the early stages of Alzheimer’s disease.
The corporate said it would redistribute a big portion of the resources related to Aduhelm to the remaining of its Alzheimer’s drug portfolio.
Among the many other Alzheimer’s drugs Biogen has in development is BIIB080, which targets a toxic protein called tau within the brain. That treatment has shown “favorable trends” across several measures of cognition and performance in a small study.
Don’t miss these stories from CNBC PRO:
