The U.S. Food and Drug Administration has canceled an advisory
committee's meeting to review Merck & Co.'s sugammadex, further
delaying the surgery drug.
Merck said the delay is due to the agency's wanting to conduct
more site inspections related to a study. As of result, Merck does
not expect to win approval before the drug's FDA decision deadline
of April 22. Merck said it would continue to work with the FDA as
it completes its review.
Sugammadex, designed to reverse the effects of muscle-relaxation
agents used in surgery, is already available in more than 50
countries outside the U.S. and marketed as Bridion.
The committee meeting had been scheduled for March 18 and was
intended to discuss the resubmission of a new drug application for
sugammadex, which the Whitehouse Station, N.J., pharmaceutical
company acquired as part of its 2009 takeover of
Schering-Plough.
The FDA rejected Scherin-Plough's original application in 2008
citing concerns about possible allergic reactions and increased
risks of bleeding when it was used with certain blood-thinning
drugs. The agency later rejected Merck's application in 2013,
citing operational concerns. Merck had said the FDA was assessing
results of a clinical site inspection in connection to a
hypersensitivity study.
--Peter Loftus contributed to this article.
Write to Maria Armental at maria.armental@wsj.com
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