Armed with FDA panel nod, Merck hopes long-languishing sugammadex will finally win approval
- The independent FDA panel in charge of anesthesia and analgesic drug products has recommended Merck's sugammadex for approval. This is the fourth time that this anesthesia-reversal drug has been reviewed by the panel, and the drug has been rejected three times by the FDA.
- Sugammadex, which is already marketed in 70 countries, will be marketed in the U.S. as Bridion if it wins approval.
- Assuming approval, Bridion will be a first-in-class drug in the U.S. It is a selective relaxant binding agent.
Seven months ago, Bridion was rejected by the FDA's reviewing panel for the third time. The concern was 'hypersensitivity' to the drug, and because the drug had already been used in the E.U. for some time, there were numerous case reports to attest to this risk.
Case studies have showed that Bridion-relatd allergic reactions can occur suddenly and with varying degrees of severity. In one report, allergic reactions developed within three minutes in two patients. In general, Bridion-related allergic reactions include flushing, tachycardia, and rash; however, the FDA is most concerned about hypersensitive reactions that could potentially lead to anaphylaxis.
Merck re-presented the data around the hypersensivity risk issue and the panel voted 13 to 1 in favor of approval. Bridion would represent a useful new addition to the stable of drugs used to reverse anesthesia. But the FDA isn't required to follow the panel's recommendations, and could still reject the drug if it still feels uncomfortable with adverse events. A final decision is expected by December 19.
- Pharma Times FDA panel backs Merck's sugammadex