The Food and Drug Administration will not complete its review of Merck & Co's experimental medicine to reverse the effects of anesthesia until the second half of 2013, representing a three-month delay, the drugmaker said.
Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous regulatory delays but is deemed by many analysts and doctors to be one of the biggest advances in anesthesia in decades.
The FDA in 2008 said it could not approve sugammadex until Merck provided more clinical trial data related to allergic reactions and blood clots, possible side effects of the drug. Merck early this year said it had completed the necessary trials and that the FDA had accepted the company's resubmitted marketing application for the drug.
Merck spokeswoman Pam Eisele on Friday said the FDA, in notifying the drugmaker about the expected delay in making a decision on the drug, did not cite any new safety issues.
"We've maintained regular meetings and discussions with the FDA, with a commitment to making sugammadex available in the United States," she said.
Sugammadex is already sold in 75 countries under the brand name Bridion and had 2012 global sales of $261 million. That makes it a modest-sized product for Merck, the second-largest U.S. drugmaker.
Cowen and Co has projected global annual sales for the drug of $575 million by 2016, if it is approved in the United States.
It would be the first in a new class of medicines in the United States known as selective relaxant binding agents. It is designed to inactivate the effects of two widely used anesthesia drugs, rocuronium and vecuronium, and thereby help patients recover far more quickly from anesthesia.
Merck shares were down 0.7 percent at $43.97 on Friday morning on the New York Stock Exchange.
(Reporting by Ransdell Pierson in New York; editing by Gerald E. McCormick, John Wallace and Matthew Lewis)
(This story was corrected to add dropped word at end of the first sentence)