The U.S. government started a review process for national Medicare coverage of Biogen Inc.’s Alzheimer’s drug Aduhelm that was approved during June 2021 by the country’s health regulator.
The U.S. Food and Drug Administration on July 9 called for an independent federal probe into its representatives’ interactions with Biogen Inc. that led to approval of the company’s Alzheimer’s disease drug during June 2021.
Biogen Inc. on July 8 said the U.S. Food and Drug Administration narrowed use of the company’s Alzheimer’s drug after the regulatory agency drew sharp criticism for its broad approval of the drug in June 2021 without proof of clear benefit against the disease.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.
The U.S. Food and Drug Administration granted breakthrough therapy designation to Japanese company Eisai and partner Biogen’s experimental therapy lecanemab for patients with early Alzheimer’s.
The U.S. Food and Drug Administration released a sweeping series of memos revealing a clear struggle within the regulatory agency ahead of its controversial decision to approve Biogen’s Alzheimer’s drug Aduhelm.
Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging during 2022 could help shed light on whether U.S. regulators were justified in their controversial approval of a Biogen Inc. treatment without clear evidence that Aduhelm works.
Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond the company’s newly approved aducanumab hit a clinical snag as the anti-tau antibody gosuranemab failed to meet endpoints in a Phase II study and was discontinued.
Pivoting from conflicting and controversial press over the company’s approved Alzheimer’s disease treatment, Biogen announced that its gene therapy drug timrepigene emparvovec failed to show a clinically meaningful benefit for a rare inherited eye disease in a Phase III trial.
Two members of a panel of outside advisors to the U.S. Food and Drug Administration resigned in protest at the regulatory agency’s decision to approve Biogen Inc.’s Aduhelm for the treatment of Alzheimer’s disease despite the committee’s recommendation against doing so.