Recothrom approved by the FDA

USA-based drug developer ZymoGenetics says that the Food and Drug Administration has approved Recothrom (recombinant thrombin) for bleeding control during surgery. Specifically, the product has been cleared for use as a topical hemostasis aid in the treatment of minor bleeds, when standard surgical techniques are impractical or ineffective.

In trials, the drug, an artificial form of human thrombin, demonstrated comparable therapeutic efficacy to current commercially-available bovine-derived thrombin products. In addition, it induced a significantly lower incidence of antibody formation than competitor products.

Last year, ZymoGenetics licensed ex-US rights to the drug to Bayer HealthCare, part of Germany's Bayer group (Marketletter June 25, 2007). Under the terms of that deal, Bayer is required to make a $40.0 million milestone payment, on the achievement of US approval. In addition, the German firm has agreed to provide support for Recothrom in the USA for a period of three years.