RecothromTreatment for Hemostasis During Surgery
Update: Recothrom Now FDA Approved - January 17, 2008
FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review
SEATTLE, February 15, 2007 -- ZymoGenetics, Inc. today announced that the Biologics License Application for recombinant human thrombin (rhThrombin) has been accepted for review by the U.S. Food and Drug Administration (FDA). ZymoGenetics is developing rhThrombin as a general aid to achieving hemostasis during surgery.
"We're extremely pleased that the FDA accepted our Biologics License Application for rhThrombin for review," said Bruce L.A. Carter, President and Chief Executive Officer. "In the past, recombinant products have quickly replaced animal and human plasma products, so we're excited about the potential opportunity to compete in the thrombin market. We believe based on our market research that we can attain a substantial share of the existing bovine thrombin market and that there is significant potential to grow the use of thrombin in surgical procedures through increased awareness."
The Biologics License Application for rhThrombin was submitted to the FDA on December 15, 2006 and the Prescription Drug User Fee Act (PDUFA) date is October 18, 2007. The Phase 3 pivotal study, which was completed in the fall of 2006, showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the marketed 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.
- ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery December 18, 2006
Posted: February 2007
- FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant) - January 17, 2008
- ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery - December 18, 2006