An independent panel for the U.S. Food and Drug Administration (FDA) voted unanimously for the approval of Merck & Co’s drug as safe to use to reverse the effects of muscle relaxants used during surgery.
The drug sugammadex, manufactured as BRIDION by Merck, has been previously rejected several times by the FDA despite being approved for use in more than 70 countries worldwide.
The approval of this drug for use in the U.S. will help address the shortcomings associated waith the current surgical anesthesia practice that is riddled with several adverse effects.
Its most recent rejection happened last April 2015, in 2013 and 2008, FDA cited concerns regarding the potentially dangerous adverse effects and allergic reactions associated with the drug that led to it being disapproved.
This was despite the fact that a previous FDA advisory reported that the committee backed the drug receiving approval.
Despite these rejections however, Merck is still determined to push through getting FDA approval for the drug they believe can greatly help prevent neuromuscular problems during surgery.
“We believe that BRIDION has the potential to offer anesthesia professionals an important new option to reverse neuromuscular blockade in the surgical setting,” said Dr. David Michelson, head of global clinical development for neuroscience, Merck Research Laboratories.
The independent panel at the FDA said that it was satisfied with the risk-benefit ration concerning potential cardiac and hypersensitivity reactions associated with the use of the drug in a monitored setting.
The panelists added that FDA had approved of drugs that carried similar risks, though majority of them also suggested that additional studies should be carried out to evaluate risks of the drug when used on vulnerable populations such as pediatric, pregnant and elderly patients.
Merck is hopeful that this vote would mean that sugammadex will get the approval the company long sought.
“Today’s discussion 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,” Michelson said.
Once approved, sugammadex will be the first kind of selective relaxant binding agent to be sold in the U.S. It can reverse neuromuscular block due to use of anesthetic agents rocuronium or vecuronium and is delivered by intravenous (IV) injection.