FDA Awards Merck Approval for Bridion
After years of waiting, Merck finally has scored FDA approval for its Bridion injection for reversing neuromuscular blockade induced by anesthesias rocuronium and vecuronium.
Patients receiving Bridion (sugammadex) — which was evaluated in three Phase 3 trials with 456 participants — showed faster recovery time than those in the comparator groups, with most participants recovering within five minutes of routine use of the drug.
The approval follows a unanimous recommendation from the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee in November. Bridion previously had been held back by the agency over safety and data integrity concerns.
Merck spokeswoman Pamela Eisele said the pricing of the drug will become available once it is launched in January 2016.