FDA Advisory Committee to review sugammadex again on 6 November 2015- Merck

Sugammadex, from Merck, is an injectable drug intended to reverse neuromuscular blockade induced by rocuronium or vecuronium during use in surgery. The drug is approved in the EU and marketed in 60 countries as Bridion. However, Merck has encountered repeated problems in progressing its application for approval at the FDA. It is now to be reviewed by the Pulmonary,Allergy and Rheumatology Advisory Committee on 6 November 2015.

The concerns at the FDA are focused on anaphylaxis and hypersensitivity events. The FDA has rejected the drug three times since 2008. Merck has conducted a hypersensitivity study, Protocol 101, to support its re-application which showed frequency of anaphylaxis was 0.33%, or 1 in 299, according to the regulators. They have commented that the anaphylaxis and hypersensitivity increases with repeated doses. There is also a concern with cardiac dysrhythmias as a side effect. The Advisory Committee will vote on whether the efficacy, safety and overall risk-benefit profile of sugammadex supports the approval of Merck's NDA.