FDA
21st December 2015

FDA Panel Votes Unanimously in Favor of Sugammadex

On November 6th, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted unanimously in favor of sugammadex (Bridion) approval for the reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium during surgery.

FDA Panel Votes Unanimously in Favor of Sugammadex

On November 6th, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted unanimously in favor of sugammadex (Bridion) approval for the reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium during surgery.

In a 13 to 1 vote, the committee agreed that the sponsor, Merck, had presented sufficient data to appropriately characterize the risk of hypersensitivity/anaphylaxis. Furthermore, the agency voted unanimously that Merck presented adequate data in characterizing the risk of cardiac dysrhythmias.

Sugammadex functions by binding to neuromuscular blocking agents, rocuronium and vecuronium, which are used to facilitate endotracheal intubation and mechanical ventilation.

Voting committee chair, Randall P. Flick, MD, MPH, Director at the Mayo Clinic Children’s Center in Rochester Minnesota stated, “very rarely we have drugs that come in to anesthesia, and I presume that the same is true in other areas, that have the potential to add significantly to the armamentarium, and this is one of those drugs. That’s not to say that there aren’t concerns, that’s not to say that this drug like many drugs we use in anesthesia will have to be used carefully and thoughtfully with an eye on the potential adverse events.”

The FDA has denied approval of sugammadex multiple times since 2007. The agency has refused to approve the drug due to adverse events (AEs) such as cardiac arrhythmias, hypersensitivity reactions, and anaphylaxis. However, during the most recent AdComm, the sponsor presented new safety data, which included an analysis of AEs from phase 1 to phase 3 studies, as well as an analysis of postmarketing data.

On December 15th, the FDA approved sugammadex injection for the noted indication.

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