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Old Mon Mar 19, 2007, 12:47 AM
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FDA Approves Soliris for PNH Treatment

The U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) as the first drug for treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis.

Patients with PNH are missing a specific protein that normally protects red blood cells from destruction by a component of the immune system called terminal complement. Soliris, the first complement inhibitor approved in the U.S. for the treatment of any disease, prevents hemolysis by selectively blocking terminal complement.

Alexion Pharmaceuticals, Inc., makers of Soliris, have also introduced Soliris OneSource, a treatment support service for all PNH patients and their healthcare providers. Enrolled patients receive support from Alexion case managers, who will provide education about PNH and Soliris and help patients obtain Soliris.

Alexion's goal is that all PNH patients who can benefit from Soliris will have access to it. Patients and their health care providers can learn more about OneSource by vistiting the website or calling 1-888-SOLIRIS (1-888-765-4747).
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