Merck Statement on FDA Advisory Committee Meeting About Sugammadex Sodium Injection
July 16, 2013 11:01 am ET
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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