The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection.
Prior to beginning Soliris therapy, all patients and their prescribing physicians are enrolled in the Soliris Safety Registry which is part of a special risk management program that involves initial and continuing education and long-term monitoring for detection of new safety findings.
Please see full prescribing information at www.soliris.net.
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to
develop and deliver life-changing drug therapies for patients with serious and
life-threatening medical conditions. Alexion is engaged in the discovery,
development and commercialization of therapeutic products aimed at treating
patients with a wide array of severe disease states, including hematologic
diseases, cancer, and autoimmune disorders. In March 2007, the FDA granted
marketing approval for Alexion's first product, Soliris, for all patients with
PNH, and Alexion began commercial sale of Soliris in the U.S. during April
2007. In June 2007, the EC granted marketing approval for Soliris in the
European Union for all patients with PNH. Alexion is evaluating other
potential indications for Soliris as well as other formulations of eculizumab
|SOURCE Alexion Pharmaceuticals, Inc.|
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