Merck & Co's drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repeatedly been rejected by the FDA due to concerns about potentially dangerous allergic reactions, even though it is approved in more than 75 countries.
A majority of the voters suggested additional studies to evaluate risks in vulnerable populations such as the elderly and obese, pediatric and pregnant patients. Sugammadex, an injectable drug, is sold in over 50 countries. More than 12 million doses of the drug have been sold as of April 22 since it was first approved in 2008 in Europe. Sugammadex, if approved in the United States, could generate annual sales of $550 million in the country by 2020. This will make the drug, sold overseas under the brand name Bridion, a moderate-sized product for Merck.
FDA staff had noted that hypersensitivity related to the drug appeared to increase with higher doses, but not with repeated exposure.
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