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FDA Approves Soliris for Rare Pediatric Blood Disorder
Date:9/23/2011

SILVER SPRING, Md., Sept. 23, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Soliris (eculizumab) 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.

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Atypical HUS accounts for 5 to 10 percent of all cases of hemolytic uremic syndrome. The disease disproportionately affects children.

Soliris is a targeted therapy that works by inhibiting proteins that play a role in aHUS.  The FDA first approved Soliris in March 2007 to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death.  Soliris is classified as an orphan drug. Orphan drugs are those that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

There are no other FDA-approved treatments for aHUS, and the safety and effectiveness of current standard treatment, plasma therapy (plasma exchange or fresh frozen plasma infusion), have not been studied in well controlled trials.

"This is the first approval of a drug for treating this life-threatening disease, and the first approval for use of Soliris in children," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approval underscores how an increased understanding of the biology of a disease and of how a drug interacts with that process can expedite drug development."

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 Soliri
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SOURCE U.S. Food and Drug Administration
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