Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patient...(('Company Sanpshot')); ALXN ) isthe fir...),Health

Date:12/10/2007

('Company Sanpshot'));" >ALXN), is the first therapy approved for PNH, a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is a complement inhibitor indicated for the treatment of patients with PNH to reduce hemolysis. In patients with PNH, hemolysis can cause thromboses, kidney disease, liver dysfunction, disabling fatigue, impaired quality of life, recurrent pain, shortness of breath, pulmonary hypertension, intermittent episodes of dark colored urine (hemoglobinuria), and anemia.(1-3)

Impaired kidney function is common among patients with PNH, (4-8) and kidney failure is the cause of death in 8 to 18 percent of PNH patients. (9) Kidney damage in PNH patients is likely due to repetitive exposure of renal tissue to cell-free plasma hemoglobin that is released during hemolysis. (10)

High Incidence of Progression to Chronic Renal Insufficiency in Patients with PNH and Impact of Long-Term Soliris Therapy

Among 195 patients enrolled in three multinational clinical trials of Soliris for the treatment of PNH, 65 percent presented at baseline with some degree of Chronic Kidney Disease (CKD) at baseline as determined from screening visit samples using criteria from the National Kidney Foundation; CKD was severe in 21 percent of patients. The analysis of patient data prior to study entry showed that the probability of progression of this overall untreated population of PNH patients to a major clinical kidney event, including severe renal damage, renal insufficiency, renal impairment, dialysis and later-stage CKD, was approximately 87 percent.

In an analysis of the overall PNH study population, long-term Soliris therapy of up to 18 months was associated with a significant improvement or stabilization of kidney function in PNH patients, irrespective of stage of baseline CKD. Of 166 patients who had completed 18 months of treatment, 65 percent had CKD at baseline. In these
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SOURCE Alexion Pharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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