FDA
17th July 2013

Merck’s Sugammadex Delayed Again at FDA

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

Merck’s Sugammadex Delayed Again at FDA

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.

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

Muscle relaxants are typically used as part of the anesthesia process at the beginning of an operation to help doctors insert a breathing tube. They can also be used during surgery to prevent muscle movements that could complicate a procedure.

After surgery, physicians commonly use reversal agents to undo the effects of these muscle relaxants so that patients can breathe, eat and swallow on their own. Sugammadex is the first in a new class of drugs designed to reverse the effect of the muscle relaxants rocuronium and vecuronium and has shown to act much faster than other reversal drugs such as neostigmine.

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. 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 March, the FDA said it would not complete its review of sugammadex until Merck provided more clinical data on allergic reactions, though Merck said at the time it had completed the necessary trials and that the FDA had accepted its resubmitted marketing application.

Sugammadex is already approved in more than 50 countries, where it is sold under the brand name Bridion.

 

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