FDA reviewers accept sugammadex data

In sugammadex from Merck & Co. Inc. (NYSE:MRK), agency reviewers said the company has resolved the agency's concerns over the integrity of hypersensitivity data and asked panelists to vote on whether there are sufficient data to characterize the risk of hypersensitivity and anaphylaxis.

Merck is seeking approval of the cyclodextrin derivative for reversal of moderate or deep neuromuscular blockade induced by the muscle relaxants rocuronium or vecuronium. FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet Friday to discuss the NDA. ...