U.S. Agency to Review FDA's Approval of Alzheimer's Drug
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New York, Aug. 4 (Jiji Press)--The Office of Inspector General at the U.S. Department of Health and Human Services said Wednesday that it will review the process of the U.S. Food and Drug Administration's approval of a new remedy for Alzheimer's disease.
The remedy, called aducanumab, was developed jointly by Japan's Eisai Co. <4523> and U.S. biopharmaceutical company Biogen Inc.
The FDA gave its approval for the drug in June with the use of its accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions. The remedy became available for use in the same month.
However, concerns have been raised over the FDA's decision as an advisory committee to the FDA voted against the approval.
Acting FDA Commissioner Janet Woodcock in July called on the OIG to investigate whether interactions between the FDA and Biogen during the approval process were appropriate.
[Copyright The Jiji Press, Ltd.]