FDA Cancels Advisory Panel's Meeting on Merck Surgery Drug -- Update

   By Maria Armental and Peter Loftus 
 

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 agency intends to conduct more inspections of sites involved in a study of patient hypersensitivity to the drug. Merck said it expects to receive a letter from the FDA by April 22, the targeted action date, saying the application is not yet ready for approval. 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 and had sales of $340 million in 2014.

The committee meeting, scheduled for March 18, 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 Schering-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.

Shares, up 0.73% over the past 12 months, edged down 0.5% to $55.93 in recent after-hours trading.

Write to Maria Armental at [e-mail] and Peter Loftus at [e-mail]

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