The Biogen headquarters in Cambridge, Massachusetts, on Tuesday, Oct. 24, 2023.
Vanessa Leroy | Bloomberg | Getty Images
Biogen on Wednesday mentioned it’s going to discontinue the sale and improvement of its older and extremely controversial Alzheimer’s drug Aduhelm to refocus the corporate’s efforts to deal with the memory-robbing disease.
The biotech firm will focus on rolling out Leqembi, a newly accepted Alzheimer’s drug it developed with the Japanese drugmaker Eisai. It additionally plans to work on a slate of experimental treatments for the illness. Those medicine characterize a brand new chapter for the corporate after the polarizing launch and approval of Aduhelm.
The Food and Drug Administration greenlit Aduhelm in 2021 underneath a program that quick tracks promising treatments. But controversy shrouded the choice as some consultants had issues about whether or not the advantages of the drug outweighed its dangers.
The federal Medicare program severely restricted entry to Aduhelm, limiting its gross sales potential, and an 18-month congressional investigation would later allege that the FDA’s approval course of for the drug was “rife with irregularities.”
But Biogen famous on Wednesday that its resolution to drop Aduhelm was “not associated to any security or efficacy issues.”
The firm mentioned it’s going to discontinue gross sales of the drug and has taken a one-time cost of $60 million for ending the Aduhelm program within the fourth quarter.
Neurimmune, the Swiss firm that invented the drug, will regain full rights to the medication, in accordance to Biogen.
Biogen can be terminating a post-approval medical trial on Aduhelm after failing to discover a accomplice or exterior financing for the drug. That research sought to show the therapy’s advantages for sufferers within the early levels of Alzheimer’s.
The firm mentioned it’s going to redistribute a big portion of the sources related to Aduhelm to the remainder of its Alzheimer’s drug portfolio.
Among the opposite Alzheimer’s medicine Biogen has in improvement is BIIB080, which targets a poisonous protein referred to as tau within the mind. That therapy has proven “favorable traits” throughout a number of measures of cognition and performance in a small research.