FDA Accepts Resubmission of NDA for Muscle Relaxant-Binding Drug, Sugammadex
Agency had requested more data on hypersensitivity and bleeding (Jan. 7)
The FDA has accepted the resubmission of a new drug application (NDA) for sugammadex sodium injection (Merck). The agency’s review is expected to be completed in the first half of 2013.
Sugammadex is an investigational agent for the reversal of neuromuscular blockade (NMB) induced by the neuromuscular blocking agent rocuronium (Zemuron, Merck) or vecuronium (Norcuron, Sagent Pharmaceuticals). NMB is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by inactivating rocuronium or vecuronium molecules directly by encapsulation. If approved, the drug would be the first in a new class of medicines in the U.S. known as selective relaxant-binding agents to be used in the surgical setting.
In 2008, the FDA rejected the original NDA for sugammadex, requesting additional data related to hypersensitivity (allergic) reactions and bleeding events.
Source: Merck; January 7, 2013.