Biogen says U.S. FTC, SEC probing Alzheimer’s disease drug By Reuters


© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder/File Photo


(Reuters) – The U.S. Federal Trade Commission and the U.S. Securities and Exchange Commission have asked Biogen Inc (NASDAQ:) to provide information on the approval and marketing of its new Alzheimer’s disease treatment, Aduhelm, the drugmaker disclosed in a filing.

Biogen in its annual report 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.

The SEC regulates securities markets and works to protect investors.

The U.S. Food and Drug Administration in June approved Biogen’s Aduhelm – the first treatment for Alzheimer’s in decades – despite one of its two large-scale clinical trials failing to show a benefit to patients. A panel of its expert advisers voted against the drug, and some panel members resigned.

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.

U.S. lawmakers have also launched an investigation into 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.

The FTC declined to comment and the SEC did not respond to a request for comment.

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