The Medicines Company has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending marketing authorisation for Raplixa sealant powder, the first ready-to-use, biologically active, powdered fibrin sealant that provides haemostasis in a wide range of bleeding settings. Phase III study results for the new product have been published in the Journal of the American College of Surgeons.
Clive Meanwell, chairman and chief executive officer, The Medicines Company, believes that Raplixa “will address significant medical needs and potentially offer improved hospital efficiency in patients undergoing surgery where standard surgical techniques are insufficient for improvement of haemostasis. We believe that these new products therefore represent significant market opportunities in Europe.”
“The recommendation for approval of Raplixa in the European Union potentially provides surgeons a new tool for the treatment of surgical bleeding across a wide range of surgical procedures,” said clinical investigator Robert J Porte, Section of Hepatobiliary Surgery and Liver Transplantation, University Medical Center Groningen, the Netherlands. “Raplixa is a ready-to-use dry powder, fibrin sealant which may minimise the time required for preparation and potential wastage, and can be applied directly from the vial or with a spray device, providing much needed flexibility.”
Raplixa is under active review by the US Food and Drug Administration.