FDA approves Soliris for paroxysmal nocturnal hemoglobinuria

On Friday, March 16, 2007, the U.S. Food and Drug Administration (FDA) approved Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a disorder in which abnormal breakdown of red blood cells occurs. Made by Alexion Pharmaceuticals, Soliris does not cure the disease, but treats the breakdown of the blood cells. Soliris has proven to be a safe and effective therapy for PNH in three multi-national clinical studies. Because the risk of contracting meningitis was found to be increased for individuals taking Soliris, the FDA ordered a boxed warning on the drug's labeling and said that all patients must receive meningococcal vaccination prior to being given the drug.