Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection

Merck (MSD outside the US and Canada) said it was informed that FDA has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for 18 March 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on 22 April 2015. Merck will continue to work with the FDA as it completes its review.