Bridion sugammadex regulatory update

FDA canceled the July 18 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss a resubmitted NDA from Merck for sugammadex for the reversal of neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium, which are given as part of general anesthesia to relax a patient's muscles during surgery. According to Merck, FDA said it needed additional time to assess a recently completed inspection of 1 of 4 clinical trial sites that conducted a hypersensitivity study requested by the agency.

Merck said FDA has not yet delayed the PDUFA date for sugammadex or said whether it will reschedule the meeting. The company said it expects a decision on the NDA this half, though the specific PDUFA date is not disclosed. The cyclodextrin derivative is marketed in 40 countries, including the EU and Japan (see BioCentury, March 25 & May 13). ...