UPDATE 3-Merck drug to reverse anesthesia delayed again at FDA

Tue Jul 16, 2013 6:26pm EDT
 
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By Toni Clarke

WASHINGTON, July 16 (Reuters) - U.S. health regulators need more time to review Merck & Co's application to sell sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery, the company said on Tuesday.

The announcement came after the U.S. Food and Drug Administration canceled a meeting of outside advisers who were scheduled to vote Thursday on whether to recommend the drug be approved. The FDA declined to give an explanation for its unusual last-minute cancellation.

Merck said the FDA needs additional time to assess the results of its recently completed inspection of a clinical trial site that was involved in a study of whether the drug increases the risk of allergic reactions.

In 2008 the FDA declined to approve sugammadex, citing concerns about its possible association with allergic reactions and bleeding. The advisory panel scheduled for this week was supposed to discuss Merck's revised application, which included new clinical data showing a slight increase in the risk of allergic reactions but no increase the risk of bleeding.

The study was conducted in the United States, the Netherlands, the United Kingdom and Germany.

The sudden delay surprised analysts and clinicians alike.

"I'm surprised to hear about this last-minute issue," said Dr. Glenn Murphy, an anesthesiologist and director of clinical research at North Shore University Health System in Evanston, Illinois, who was an adviser to Merck on sugammadex. "I thought everything was moving along towards getting this drug approved."   Continued...