If the endpoints in the study are met, ZymoGenetics plans to submit a biologics licensing application (BLA) for rhThrombin to the FDA in late 2006.
The 400 patient pivotal phase III clinical trial was designed to compare rhThrombin to bovine thrombin, the currently marketed product, in four surgical settings and to evaluate the safety, efficacy and immunogenicity of the two products.
“This allows us to continue to pursue our plan for submission of a BLA to the FDA by year end and, we hope, to provide an effective and safe alternative for the control of surgical bleeding,” said Dr Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics.