2022-12-30| In-DepthSpecial

The FDA and Biogen Taking Heat for Aduhelm’s Approval Process

by Reed Slater
Share To
Over a year after the FDA approved Biogen’s Alzheimer’s drug, Aduhelm, on the accelerated approval pathway, the U.S. House of Representatives published a report outlining the atypical processes leading to the drug’s approval. The report faults the FDA for abnormalities in documentation protocol, not adequately representing differing views within the regulatory agency, shifting to accelerated approval in a substantially short timeframe, and approving the drug for a broad label despite a lack of clinical evidence in a wider population. Biogen is under fire for accepting the broad label, knowing it did not test the drug in a broad population and setting a high price, and planning for substantial marketing costs, despite knowing the potential impact on patients and the Medicare system.

GO Prime with only $1.49 now

From Sweet to Risky: The Alarming Findings on Sucralose’s Genotoxicity
GHG Emissions as a ESG Metric
NSTC Joins Forces with Taiwan Biomedical Start-ups to Rise to the World Stage, Showcasing Innovations at US BIO’s Demo Day
Krystal Biotech’s First Topical Gene Therapy Approved by FDA
The Emergence of General AI for Medicine: Medical Applications of ChatGPT
Strengthening Genetic Screening Platform in APAC for Lung Cancer Precision Medicine: An Interview with Dr. Koichi Goto
2023 International Healthcare Week: Showcasing Emerging Competencies of Hong Kong’s Biomedical Industry
Scroll to Top