Merck Meeting Before FDA Canceled for Inspection ReviewAnna Edney
Merck & Co. said a meeting of U.S. advisers this week to assess its experimental anesthesia-reversal drug was canceled to allow regulators more time to review the results of an inspection at a clinical trial site.
A Food and Drug Administration advisory panel was set to meet July 18 to discuss sugammadex, which enables the muscle movement necessary in a patient to extract a breathing tube after surgery. The trial site the FDA is concerned with is one of four where potential allergic reactions associated with the drug were studied, Merck said in a statement today.
Merck has been pursuing a second chance for the drug in the U.S. after the FDA rejected sugammadex in 2008 because of the potential for allergic reactions and bleeding. Sugammadex, which is approved in 40 other countries as Bridion, may be used in 25 percent of the 30 million general anesthesia surgeries conducted each year in the U.S. if cleared by the FDA, Whitehouse Station, New Jersey-based Merck said on a May 1 conference call.
“Sugammadex is an important treatment option for an unmet medical need in anesthesia, and we will work with the FDA on the next steps to bring this innovation forward to patients in the U.S.,” David Michelson, Merck’s head of global clinical development for neuroscience, said in the statement.
The hypersensitivity study was conducted in the U.S., Netherlands, the U.K. and Germany, said Pamela Eisele, a Merck spokeswoman.
Sugammadex brought in $261 million in sales last year for Merck. Sales may reach $513 million in 2016 with FDA approval, according to the average of seven analysts’ estimates compiled by Bloomberg.
Sugammadex is intended for reversal of neuromuscular blocking agents rocuronium and vecuronium, which assist with intubation by preventing coughing or gagging. The drug is designed to work faster than existing treatments.