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

(Reuters) – The U.S. Federal Commerce Fee and the U.S. Securities and Trade Fee have requested Biogen Inc (NASDAQ:) to offer info on the approval and advertising and marketing of its new Alzheimer’s illness therapy, Aduhelm, the drugmaker disclosed in a submitting.

Biogen in its annual report on Thursday mentioned it obtained a civil investigative demand, just like a subpoena, from the FTC. The FTC is tasked with oversight of business competitors and client safety.

The SEC regulates securities markets and works to guard buyers.

The U.S. Meals and Drug Administration in June accepted Biogen’s Aduhelm – the primary therapy for Alzheimer’s in a long time – regardless of one among its two large-scale scientific trials failing to point out a profit to sufferers. A panel of its professional advisers voted in opposition to the drug, and a few panel members resigned.

In July, the FDA requested the Workplace of the Inspector Basic for the Division of Well being and Human Companies to open an investigation into interactions with Biogen associated to the approval of the drug.

U.S. lawmakers have additionally launched an investigation into the drug.

Because the launch, gross sales of Aduhelm have been gradual and Biogen minimize the worth by 50% in December.

In January, the U.S. Medicare well being plan for the disabled and people aged 65 and over, the age group during which Alzheimer’s illness is most prevalent, proposed masking the drug just for folks enrolled in a brand new scientific trial. A remaining plan is predicted in April.

Biogen mentioned within the submitting that the businesses had been looking for info associated to healthcare websites, the approval and advertising and marketing.

The FTC declined to remark and the SEC didn’t reply to a request for remark.