In its annual SEC report, Biogen reported that the Federal Trade Commission had sent the company a civil investigative demand related to the controversial Alzheimer’s drug aducanumab (Aduhelm).
The company received a similar notice from the SEC.
Lawmakers in the U.S. House of Representatives and the Office of Inspector General of HHS are also investigating the approval and marketing of the drug.
The House Committee on Oversight and Reform had balked at Biogen’s initial plan to price the drug at $56,000 for a patient with an average weight. However, the company later cut the cost by approximately half.
Aducanumab exemplifies one of the most troubled drug rollouts in recent memory.
CMS has proposed drastically limiting coverage of aducanumab and other future drugs until more convincing efficacy data are available.
Aduhelm generated approximately $3 million in revenue in 2021.