Merck in Talks with FDA to Identify Steps Needed for Review of Sugammadex Sodium Injection
Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed today that the U.S. Food and Drug Administration (FDA) has cancelled Thursday's discussion of sugammadex at the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Sugammadex sodium injection is Merck's investigational medicine for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium.
The FDA advised Merck that the agency needs additional time to assess the results of the FDA's recently completed inspection of a clinical trial site. The site was one of four sites that conducted the hypersensitivity study previously requested by the agency. Merck is engaged in discussions with the FDA to identify the steps necessary to enable the agency to complete its review.
“Merck believes that sugammadex is an important treatment option for an unmet medical need in anesthesia, and we will work with the FDA on the next steps to bring this innovation forward to patients in the United States,” said David Michelson, M.D., head of global clinical development for neuroscience, Merck Research Laboratories.
Sugammadex is marketed in 40 countries other than the U.S., and more than five million vials of sugammadex have been sold as of March 2013.
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