RecothromTreatment for Hemostasis During Surgery
Update: Recothrom Now FDA Approved - January 17, 2008
ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery
SEATTLE, December 18, 2006 -- ZymoGenetics, Inc. today announced that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for licensure to market recombinant human thrombin (rhThrombin) as a general aid to achieving hemostasis during surgery.
"Submitting the biologics license application for rhThrombin is an important milestone for ZymoGenetics," said Bruce L.A. Carter, President and Chief Executive Officer. "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."
As previously disclosed, the Phase 3 pivotal study showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the approved bovine thrombin product.
ZymoGenetics is developing rhThrombin, a recombinant form of human thrombin that is not derived from animal or human blood, as an aid to controlling bleeding during surgery. Thrombin is used in more than 1 million surgeries each year in the United States. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone 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. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.
Source: ZymoGenetics, Inc.
Posted: December 2006
- FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant) - January 17, 2008
- FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review - February 15, 2007