OMRIX SUBMITS EVICEL SBLA FOR GENERAL HEMOSTASIS IN SURGERY

Omrix Biopharmaceuticals announced it has submitted a supplemental biologics license application (sBLA) to the FDA for approval to market Evicel, the company's second-generation liquid fibrin sealant, with an expanded indication of general hemostasis in surgery.

Evicel was originally approved to control bleeding during liver surgery, and the company has been seeking to expand the drug's indication by conducting trials in various types of surgery. The sBLA contains the results of a prospective, randomized, multicenter, Phase III, controlled study comparing Evicel with standard-of-care in 135 retroperitoneal or intra-abdominal surgery patients.

"With the expected approval of this sBLA, Omrix will have the only fibrin sealant in the U.S. with a general hemostasis indication in surgery," Robert Taub, the company's president and CEO, said. "Our investment to complete the development process with our partner, Ethicon, is a testament to our long-term commitment to bring safe and efficacious active hemostats to the market. When approved, this expanded indication will allow our marketing partner to exploit the full potential of this product."