Merck & Co Inc said it expects its long-delayed drug to reverse the effects of anesthesia to be denied U.S. approval after U.S. regulators said they need to conduct more site inspections related to a study of the drug.
Merck on Friday said it expects a so-called complete response letter from the U.S. Food and Drug Administration by April 22. Such letters indicate that the agency is unwilling to approve a drug until certain conditions are met.
A March 18 meeting of an independent FDA medical advisory panel to discuss the company's resubmitted marketing application has been canceled, Merck said, adding that the company will continue to work with the FDA as the agency completes its review.
Sugammadex, which reverses the effects of muscle relaxants after surgery, is already approved in more than 50 countries.
Cowen & Co, a brokerage, has estimated that sugammadex, if approved in the United States, could capture annual sales of $550 million by 2020, which would make it a moderate-sized product for Merck. It is sold overseas under the brand name Bridion.
It was developed by Schering Plough, a rival U.S. drugmaker acquired by Merck in 2009, and has been billed by the drugmakers for years as a potential major advance in speeding recovery of patients from anesthesia.
The FDA rejected the injectable drug in 2008, citing concerns about a possible association with allergic reactions and bleeding.
(Reporting by Natalie Grover in Bengaluru; Editing by Simon Jennings and Richard Chang)