Merck 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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