This picture offered by Biogen on Monday, June 7, 2021 exhibits a vial and packaging for the drug Aduhelm. (Biogen by way of AP, File)
The U.S. antitrust regulator has requested Biogen Inc to current paperwork associated to the approval and advertising of its Alzheimer's illness therapy, the drugmaker disclosed in a submitting.
Biogen in its annual report on Thursday stated the U.S. Federal Commerce Fee had despatched it a civil investigative demand, much like a subpoena.
It has additionally obtained an inquiry from the U.S. Securities and Trade Fee searching for info over Aduhelm, which obtained a controversial approval final yr, Biogen stated.
The U.S. Meals and Drug Administration in June authorized Biogen's Aduhelm regardless of a panel of its skilled advisers voting towards the drug, resulting in a few of the panel members resigning and U.S. lawmakers launching an investigation into the drug.
Gross sales of Aduhelm have since stalled because it faces uncertainty over protection from the U.S. Medicare well being plan for these aged 65 and over, the age group through which Alzheimer's illness is most prevalent.
(Reporting by Manas Mishra in Bengaluru; modifying by Shinjini Ganguli)
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