The U.S. Food and Drug Administration’s (FDA) approval process of the controversial and costly new Alzheimer’s drug Aduhelm was “rife with irregularities” and “highly atypical,” according to a report released on Dec. 29 by the House Oversight and Energy and Commerce committees.
The report (pdf) is the result of an 18-month investigation conducted by the Committee on Oversight and Reform, and Committee on Energy and Commerce into the regulatory review and approval, pricing, and marketing of the Massachusetts-headquartered biotechnology company Biogen Inc.’s Alzheimer’s disease drug, aducanumab, which is widely known by the name Aduhelm.
Aduhelm was granted accelerated approval by the FDA in June 2021 after data from clinical trials showed a reduction in the amyloid-beta plaques of the brain, which “is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”…