Merck & Co’s neuromuscular blockade antidote sugammadex has cleared a significant hurdle to market after winning backing from a panel of US regulatory advisors for the reversal for general anaesthesia.
The US Food and Drug Administration’s Anaesthetic and Analgesic Drug Products Advisory Committee voted unanimously in favour of approving the drug for the reversal of neuromuscular blockade induced by the agents rocuronium or vecuronium.
Sugammadex, which is to be marketed under the tradename Bridion, has been knocked back three times in the US as regulators stalled over its potential to set off serious allergic reactions.
However, the Committee voted 13 to one that Merck has presented enough information on the risk for hypersensitivity/anaphylaxis, and unanimously that there was enough information on the risk of cardiac dysrhythmias.
“We believe that Bridion has the potential to offer anaesthesia professionals an important new option to reverse neuromuscular blockade in the surgical setting,” said David Michelson, head of global clinical development for neuroscience, Merck Research Laboratories.
The FDA isn’t bound by the Committee’s decision, and is expected to make its position on the drug known by December 19. If approved, Bridion would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the US.
The drug is already marketed in more than 70 countries around the globe.