After several knockbacks, Merck & Co has finally moved a key step closer to securing FDA approval for its muscle relaxant reversal agent Bridion.
Bridion (sugammadex) was first rejected by the FDA in 2008, and was turned down once again in 2013. While the FDA still has to deliver a final verdict on the marketing application, a unanimous vote in favour of the drug by an agency advisory committee yesterday suggests the project is back on course.
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.
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, said Merck in a statement.
The drug has been available in dozens of countries outside the US for several years, pulling in around $340m in sales last year, but accessing the huge US market could provide a significant uptick in its turnover, perhaps as much as $500m a year by 2020.
The FDA’s previous reticence has hinged upon hypersensitivity or allergic reactions seen in Bridion-treated patients, as well as the design of a study set up to investigate the possible link. Earlier this year, the agency delayed an advisory committee meeting on the drug in order to allow time to carry out 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 these have side effects and provide only slow and unpredictable recovery from NMB.
The FDA panel vote “is one step in the regulatory process, and we look forward to working with the FDA as it completes the review of our New Drug Application for Bridion,” said Michelson.