FDA advisory panel backs Merck's Bridion for NMB

The Anesthetic and Analgesic Drug Products Advisory Committee of the US Food and Drug Administration on Friday discussed pharma giant Merck & Co’s (NYSE: MRK) Bridion (sugammadex), coming to a favorable conclusion on approval of the investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium.

These independent FDA advisers said that they were satisfied with the potential hypersensitivity and cardiac risk associated with the drug when it was used in a monitored setting. Panelists underscored the fact that existing agents carried similar risks. A majority of the voters, however, suggested additional studies to evaluate risks in vulnerable populations such as the elderly and obese, pediatric and pregnant patients.

Sugammadex has previously been rejected by the FDA due to concerns about potentially dangerous allergic reactions, even though it is marketed in more than 75 countries.