OMRIX SUBMITS BLA FOR STANDALONE HUMAN THROMBIN

Omrix Biopharmaceuticals has submitted a biologics license application (BLA) to the FDA for approval to market thrombin as a standalone product with a general hemostasis indication in surgery.

The FDA has allowed the company to cross-reference the chemistry, manufacturing and controls (CMC) and preclinical sections of its Evicel file. Evicel is Omrix's currently marketed fibrin sealant product indicated as an adjunct to hemostasis in patients undergoing liver surgery.

The thrombin BLA filing is based on, and contains data from, a Phase III clinical trial that 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.

The antibody data generated in the clinical study showed that one patient who received human thrombin was considered to be 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.