UPDATE 1-Merck says FDA needs more time to complete sugammadex review
July 16 (Reuters) - Merck & Co Inc said on Tuesday that U.S. health regulators need more time to review its application to sell sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery.
The announcement came after the U.S. Food and Drug Administration canceled a meeting of outside advisers that had been set for Thursday. Merck said the FDA told the company it needed additional time to assess the results of its recently completed inspection of one of Merck's clinical trial sites.
In 2008 the FDA declined to approve sugammadex, citing concerns about its possible association with allergic reactions and bleeding.
The canceled advisory panel was supposed to discuss Merck's revised application, which the company says includes data showing the drug slightly increases the risk of allergic reactions but does not increase the risk of bleeding.
Merck said the site the FDA is still evaluating was one of four involved in the company's latest trial to test the drug's potential to cause allergic reactions.
Sugammadex is the first in a new class of drugs, known as selective relaxant binding agents, that are designed to reverse the effect of the muscle-relaxants rocuronium and vecuronium. Merck acquired sugammadex when it bought Schering-Plough for $41 billion in 2009.
Sugammadex is already approved in more than 50 countries, where it is sold under the brand name Bridion. It generated worldwide sales of $261 million in 2012.
Merck's shares were down 0.5 percent to $48.27 on the New York Stock Exchange.