Merck gets unanimous vote for FDA backing of Bridion
After several setbacks, Merck & Co has finally achieved an important milestone to securing FDA approval for its muscle relaxant reversal agent Bridion.
Bridion (sugammadex) was first rejected by the FDA back in 2008, and was again turned down once in 2013. While the FDA still needs to deliver its final verdict on the marketing application, there was a unanimous vote in favour of the drug by an agency advisory committee yesterday which suggests the project is back on track.
Merck is seeking approval of Bridion for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium, which are used during surgical procedures, and is now waiting for a decision from the FDA by the action date of December 19.
Merck stated that if approved, Bridion would be the first in a new class of medicines to be used in the US, known as selective relaxant binding agents.
The drug has been available in dozens of countries outside the US for several years and pulled in around $340m in sales last year, but accessing the huge US market could provide a significant boost for its turnover.
The FDA’s previous reservations were hinged upon hypersensitivity or allergic reactions that were seen in Bridion-treated patients, and the design of a study set up to investigate the possible link. As a result, the agency delayed an advisory committee meeting on the drug due to take place early this year in order to allow extra time for an audit of sites involved in the study.
A FDA report published last week noted that hypersensitivity related to the drug appeared to increase with higher doses, but not with repeated exposure.
“We believe that Bridion has the potential to offer anaesthesia professionals an important new option to reverse neuromuscular blockade in the surgical setting,” said Dr David Michelson, head of global clinical development for neuroscience at Merck Research Laboratories.
Older muscle relaxant drugs such as neostigmine and edrophonium are used in the US, but tend to have side effects and provide only slow/unpredictable recovery from NMB.