Merck has received a Complete Response Letter from the FDA for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
The FDA’s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near future. Earlier, the FDA cancelled the discussion of sugammadex at the July 18th Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). At that time, the FDA advised Merck that the agency needed additional time to assess the results of the agency’s recently completed inspection of a clinical trial site conducting the hypersensitivity study.
“We believe sugammadex is an important innovation, and will work closely with the FDA to bring this product to hospitals, surgeons, anesthesia professionals and patients in the United States,” said David Michelson, M.D., head of global neuroscience clinical development, Merck Research Laboratories.
Sugammadex is currently marketed in more than 50 countries other than the U.S., and more than 5 million vials have been sold as of June 2013.