Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced that
Soliris(R) (eculizumab), its first-in-class complement inhibitor, has
been granted Orphan Medicinal Product Designation by the European
Commission for the treatment of patients with atypical Hemolytic Uremic
Syndrome (aHUS).
AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009.
Soliris is approved in the United States, European Union, Australia and Canada as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating, and life-threatening blood disorder. Soliris has also been designated as an orphan drug in these countries, as well as in Japan, for the treatment of patients with PNH.
About the aHUS Clinical Studies
Atypical Hemolytic Uremic Syndrome is characterized by chronic inflammation, hemolysis (red blood cell destruction), thrombocytopenia (reduced circulating platelets), and microangiopathy (damage in small blood vessels), particularly in the kidney and brain, often progressing to end-stage kidney disease or failure. Like PNH, aHUS is caused by a deficiency in normally occurring complement inhibitor proteins.
Physicians, patients and care givers who are interested in participating in these clinical trials can learn more by contacting Alexion by e-mail at clinicaltrials@alxn.com, or by visiting the Alexion website at www.alexionpharma.com and clicking on the clinical trials link. The ongoing trials are also posted to the www.clinicaltrials.gov website maintained by the U.S. National Institutes of Health.
AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009.
Soliris is approved in the United States, European Union, Australia and Canada as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating, and life-threatening blood disorder. Soliris has also been designated as an orphan drug in these countries, as well as in Japan, for the treatment of patients with PNH.
About the aHUS Clinical Studies
Atypical Hemolytic Uremic Syndrome is characterized by chronic inflammation, hemolysis (red blood cell destruction), thrombocytopenia (reduced circulating platelets), and microangiopathy (damage in small blood vessels), particularly in the kidney and brain, often progressing to end-stage kidney disease or failure. Like PNH, aHUS is caused by a deficiency in normally occurring complement inhibitor proteins.
Physicians, patients and care givers who are interested in participating in these clinical trials can learn more by contacting Alexion by e-mail at clinicaltrials@alxn.com, or by visiting the Alexion website at www.alexionpharma.com and clicking on the clinical trials link. The ongoing trials are also posted to the www.clinicaltrials.gov website maintained by the U.S. National Institutes of Health.
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