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news.The European Medicines Agency has adopted a positive opinion recommending marketing authorization for Alexion Pharmaceuticals' Soliris for the treatment of an illness that causes the destruction of red blood cells.
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Based upon the positive recommendation, marketing authorization by the European Commission is expected in two to three months.
Soliris, a designated orphan medicinal product, is intended to reduce hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH). The agency recommended a broad label for Soliris covering all patients with PNH.
Soliris has already been approved by the FDA for the treatment of PNH to reduce hemolysis. There are no therapies specifically available for the treatment of PNH in Europe.
The agency based its opinion on clinical data from three studies. 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.