The Associated Press June 1, 2011, 10:13AM ET

FDA speeds up new review of Alexion's Soliris

Alexion Pharmaceuticals Inc. said Wednesday that regulators will conduct a faster review of its drug Soliris as a treatment for a rare genetic disease that causes blood clots throughout the body.

The Food and Drug Administration will conduct a six-month priority review of Soliris as a treatment for atypical Hemolytic Uremic Syndrome, a disease in which blood clots appear in small blood vessels throughout the body. The clots can cause damage to the brain, heart, kidneys, and other organs. Alexion said Soliris could be available for U.S. patients with atypical Hemolytic Uremic Syndrome if it is approved.

The FDA usually takes 10 months to review drug candidates. It can speed up its reviews for drugs treat conditions that don't have good treatment options, or for drug candidates that would be a significant improvement on older therapies.

Alexion said about 60 percent of patients with atypical Hemolytic Uremic Syndrome either need dialysis or a kidney transplant or die within a year of being diagnosed with the disease. Patients who receive a kidney transplant often have severe complications, and more than 90 percent of them have kidney failure.

The company has also asked European Union regulators to approve Soliris in atypical Hemolytic Uremic Syndrome.

Soliris was approved in 2007 as a treatment for paroxysmal nocturnal hemoglobinuria, a disease that causes a breakdown of red blood cells and can cause anemia, blood clots, and strokes. It is Alexion's only marketed product.


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