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Old Mon Aug 6, 2012, 05:23 PM
jayframe jayframe is offline
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Soliris receives second approval for rare disease

More recently, Soliris has also been approved by the FDA to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

Soliris’ safety and effectiveness were established in two single-arm trials in 37 adults and adolescent patients with aHUS and one retrospective study in 19 pediatric patients and 11 adult patients with aHUS. Patients treated with Soliris in these studies experienced a favorable improvement in kidney function, including elimination of the requirement for dialysis in several patients with aHUS that did not respond to plasma therapy. Patients treated with Soliris also exhibited improvement in platelet counts and other blood parameters that correlate with aHUS disease activity.

Soliris is manufactured by Alexion Pharmaceuticals and has been approved by the FDA to treat aHUS since 2011.
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