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news.ZymoGenetics has said that the FDA will not require additional clinical trials with rhThrombin administered by a spray device as an aid to controlling bleeding during surgery.
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ZymoGenetics said the decision would shorten the timeline for offering spray rhThrombin by about 18 months and save substantial amounts of money for the company.
ZymoGenetics now plans to file prior approval supplements for the 20,000 Unit vial and a 20,000 Unit spray kit immediately after receiving approval of the 5,000 Unit vial. Spray configurations account for approximately one-third of the sales of the existing bovine thrombin product. The current phase II trial is expected to be completed in the second quarter.
The therapy rhThrombin is a recombinant form of human thrombin that is not derived from animal or human blood. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins and 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.
The phase III pivotal study showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the marketed bovine thrombin product.