Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer Schering Pharma has submitted a marketing authorization application to the European Medicines Agency for recombinant human thrombin as a topical aid to control surgical bleeding.
Subscribe to our email newsletter
Thrombin alfa is a recombinant form of human thrombin that is structurally and functionally similar to the natural enzyme which is an important factor in the blood clotting cascade.
Used in surgery, the product is applied topically to the operation wound and may be administered as a spray or with a surgical sponge. Upon application, thrombin alfa is said to activate the final steps of the coagulation cascade to stop the bleeding.
According to the company, Thrombin alfa would be the first stand-alone thrombin product to control bleeding during surgery and may improve the therapeutic options in Europe.
Thrombin alfa is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Thrombin alfa received FDA approval in January 2008 and is marketed as Recothrom Thrombin, topical (recombinant). Bayer plans to use the product name Recothrom globally, pending regulatory approval.