Soliris is the first therapy approved in Europe for the treatment of PNH.
Alexion is prepared to begin reimbursement discussions with healthcare systems in European countries immediately, and it expects to introduce Soliris in one or more major European markets by the end of 2007, with additional countries to follow in 2008.
The EMEA approved Soliris based on clinical data from three multi-national clinical studies involving 195 patients. In these studies Soliris reduced hemolysis in every treated patient, thereby reducing symptoms, stabilizing hemoglobin and significantly reducing transfusions. Soliris patients reported markedly less fatigue and improved health-related quality of life. Additionally, there were fewer thrombotic events during Soliris treatment than during the same period of time prior to treatment.
Soliris was previously approved by the FDA on March 16, 2007 for the treatment of PNH to reduce hemolysis (destruction of red blood cells) in the US.