Biogen is discontinuing its Alzheimer's drug Aduhelm, which was approved in 2021 but became snarled in efficacy concerns and payers' refusals to cover the medication.
The company said it sought partners or more financing for the drug's continued development and research, including a phase 4 confirmatory trial required by the FDA, but Biogen failed to find extra resources to make up the time and investment.
It will cost $60 million to shutter the Aduhelm program, Biogen said Jan. 31.
After Aduhelm's approval in summer 2021, the 25 biggest insurance companies in the U.S. refused to cover the medicine because none of them considered it "medically necessary." About a year later, a federal investigation blamed the FDA and Biogen for Aduhelm's "unjustifiably high price" and lack of clinical data.
The drugmaker is redirecting efforts to Leqembi (lecanemab-irmb), an Alzheimer's drug co-developed by Biogen and Eisai, which the FDA approved in January 2023.