ZYMOGENETICS FILES BLA FOR RECOMBINANT HUMAN THROMBIN

ZymoGenetics has submitted a biologics license application (BLA) to the FDA for approval to market recombinant human thrombin (rhThrombin) as a general aid to achieving hemostasis during surgery.

"We believe that a recombinant version of thrombin will provide important benefits to patients and healthcare providers. We're very excited about the potential of rhThrombin to significantly impact the market for hemostasis products," Bruce Carter, president and CEO of the company, said.

As previously disclosed, the Phase III pivotal study showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared with the approved bovine thrombin product.

RhThrombin is a recombinant form of human thrombin that is not derived from animal or human blood. Currently, only thrombin derived from bovine blood is available in the U.S. as a standalone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins, and in some cases these antibodies appear to be related to serious bleeding complications, according to the company.