The U.S. Federal Trade Commission and the U.S. Securities and Exchange Commission have asked Biogen Inc to provide information on the approval and marketing of its new Alzheimer's disease treatment, Aduhelm, the drugmaker disclosed in a filing.
A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder/File PhotoFeb 4 - The U.S. Federal Trade Commission and the U.S. Securities and Exchange Commission have asked Biogen Inc
to provide information on the approval and marketing of its new Alzheimer's disease treatment, Aduhelm, the drugmaker disclosed in a filing.on Thursday said it received a civil investigative demand, similar to a subpoena, from the FTC. The FTC is tasked with oversight of industry competition and consumer protection.Register now for FREE unlimited access to Reuters.comThe U.S.
In July, the FDA asked the Office of the Inspector General for the Department of Health and Human Services to open an investigation into interactions with Biogen related to the approval of the drug.Since the launch, sales of Aduhelm have been slow and Biogen cut the price by 50% in December. In January, the U.S. Medicare health plan for the disabled and those aged 65 and over, the age group in which Alzheimer's disease is most prevalent, proposed covering the drug only for people enrolled in a new clinical trial. A final plan is expected in April.
Biogen said in the filing that the agencies were seeking information related to healthcare sites, the approval and marketing.Register now for FREE unlimited access to Reuters.comReporting by Manas Mishra in Bengaluru; additional reporting by Nate Raymond and Diane Bartz, writing by Caroline Humer; Editing by Shinjini Ganguli and Cynthia Osterman
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