October 24, 2023 at Biogen headquarters in Cambridge, Massachusetts.
Vanessa Leroy Bloomberg | Getty Images
Biogen announced Wednesday that it would do so. call off sales and development Old and controversial Alzheimer's disease drug Aduhelm The move aims to refocus the company's efforts to treat diseases that rob people of their memory.
The biotechnology company will focus on rolling out its newly approved Alzheimer's disease drug Rekenbi, developed with Japanese pharmaceutical company Eisai. The company will also work on a series of experimental treatments for the disease. These drugs represent a new chapter for the company after the divisive launch and approval of Aduhhelm.
US Food and Drug Administration green light Mr. Aduhelm was appointed in 2021 under a program to rapidly develop promising treatments.but controversy The decision was overturned because some experts had concerns about whether the drug's benefits outweighed the risks.
The federal Medicare program severely restricts access to Aduhhelm, restricts its availability for sale, and prohibits it for 18 months. parliamentary investigation He later claimed that the FDA's approval process for the drug was “riddled with fraud.”
But Biogen said Wednesday that its decision to discontinue Aduhhelm was “in no way related to safety or efficacy concerns.”
The company announced it was discontinuing sales of the drug and said it had collected a one-time payment of $60 million to exit the Aduhhelm program in the fourth quarter.
According to Biogen, the Swiss company that invented the drug, Nurimune, will regain full rights to the drug.
Biogen also plans to halt post-approval clinical trials for Aduhhelm because it was unable to find a partner or external funding for Aduhhelm. The study sought to prove the benefits of the treatment for patients in the early stages of Alzheimer's disease.
The company announced that it will reallocate the majority of resources associated with Aduhhelm to the remainder of its Alzheimer's disease drug portfolio.
Other Alzheimer's disease drugs in development by Biogen include: BIIB080, targets a toxic protein called tau in the brain. The treatment showed “favorable trends” across several measures of cognition and function in a small study.
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