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Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (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.
“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.
As previously disclosed, 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.
Neuromuscular blockade is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by inactivating rocuronium or vecuronium, two neuromuscular blocking agents, directly by encapsulation. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the U.S. 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.
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This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.