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news.Omrix Biopharmaceuticals has submitted a biologics license application to the FDA for approval to market Thrombin as a stand-alone product with a general hemostasis indication in surgery.
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The biologics license application (BLA) filing is based on, and contains data from a phase III clinical trial. The trial measured and demonstrated the equivalence of topical human thrombin to bovine thrombin in achieving hemostasis in general surgery procedures in terms of safety and efficacy.
In addition, the antibody data generated in this clinical study showed that one patient who received human thrombin was considered as being positive to the product. The antibody value for this patient was just below the preset criteria for positive response. Seventeen patients who received bovine thrombin developed antibodies to bovine coagulation proteins using similar preset criteria.
“The submission of our Thrombin BLA positions Omrix one step closer to its goal of creating a one-stop-shop for surgical hemostats,” stated Robert Taub, Omrix's president and CEO. “Together with our partner Ethicon, we are advancing the clinical development of our Fibrin Patch for the control of brisk bleeding and are continuing to penetrate the liquid fibrin sealant market with Evicel in the US and Quixil in Europe.”