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 maria.armental@wsj.com and Peter
Loftus at peter.loftus@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires