The supplemental biologics license application (sBLA) contains the results of a phase III study comparing the hemostatic efficacy of Evicel to standard-of-care in retroperitoneal or intra-abdominal surgery in 135 patients. This clinical trial represents the third pivotal study performed with Evicel and meets the requirements necessary for a general hemostasis indication.
“With the expected approval of this sBLA, Omrix will have the only fibrin sealant in the US with a general hemostasis indication in surgery,” stated Robert Taub, president and CEO of Omrix Biopharmaceuticals.
Omrix said Evicel is advantageous because of its ease of use, immediate availability to the surgeon and in its bovine-free formulation. The company said it provides for important hemostasis support when conventional surgical techniques prove to be inefficient, ineffective or impractical.