Merck no longer expects April approval for surgery drug sugammadex after FDA cancels meeting

Markets Associated Press

Drugmaker Merck & Co. no longer expects its experimental injection sugammadex to be approved next month after another regulatory setback.

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The company said Friday that the Food and Drug Administration has canceled a March 18 meeting to review sugammadex, which is designed to help patients "wake up" after surgical anesthesia, to do additional inspections of sites in a trial of hypersensitivity reactions with the drug. The FDA cancelled a similar meeting in July 2013 following an inspection with the same study.

As a result of the latest delay, Merck said it does not expect to gain approval for the drug by April 22, when the FDA was to complete its review.

Merck has been trying to win U.S. approval for the drug for more than seven years. Sugammadex was previously rejected by the FDA in 2008 due to allergic reactions and bleeding among some patients.

"Merck will continue to work with the FDA as it completes its review," the company said in a statement.

The injectable drug, if approved, would be the first intended to reverse the effects of certain muscle-relaxing drugs given along with anesthesia during surgery.

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Sugammadex was approved in 2009 in European Union countries.