Baxter Files For Approval Of First Blood Substitute

Baxter Healthcare has filed for approval of HemAssist (diaspirincross-linked hemoglobin or DCLHb) with the European Medicines Evaluation Agency. It is the first company developing a blood substitute to reach the regulatory stage.

The company is seeking EMEA approval to market HemAssist as an alternative to blood in patients undergoing cardiopulmonary bypass surgery. The proposed indication is based primarily on data collected in a European cardiac surgery trial which was conducted at several medical centers in the UK, Belgium and France. The data were presented on May 6 at the European Society of Anesthesiologists meeting in Lausanne, Switzerland.

Maurice Lamy of the University of Liege in Belgium presented data on 209 cardiac bypass patients who required blood transfusions after surgery. The protocol of the HemAssist trial was designed to show that the product would reduce the need for further blood transfusions. Patients in the test group received up to three units (750ml) of HemAssist, while controls received one or more units of blood.