FDA thumbs up for Bridion to reverse neuromuscular blockade

The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s (NYSE: MRK) Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

The company said it aims to make the drug available in January 2016. Bridion was approved in European Union countries in 2009, but was rejected by the FDA, which repeatedly cancelled and rescheduled meetings to review the drug, most recently in March of this year. Brokerage firm Cowen & Co estimates that sugammadex, with its US approval, could generate annual sales of $550 million in the country by 2020. JP Morgan analysts have previously estimated that sales will grow to $979 million in 2020.

Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator.