Savient Pharmaceuticals, Inc. announced that the Marketing Authorization Application (MAA), filed by its wholly owned subsidiary, Savient Pharma Ireland Limited, seeking approval of Krystexxa (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy, has completed validation by the European Medicines Agency (EMA). The MAA has been deemed valid by the EMA which determination initiates the EMA's regulatory review process. The MAA includes safety and efficacy data from Savient's pivotal phase 3 and long-term open label extension studies of Krystexxa, as well as detailed information on non-clinical studies and chemistry, manufacturing and control of production.
John H. Johnson, chief executive officer of Savient, said, "We are pleased to have achieved this important milestone in our mission to bring relief to patients suffering from refractory chronic gout in Europe. Currently there are no EMA approved treatments for this condition available in the European Union, which demonstrates the clear unmet need for new therapies to treat patients suffering from this debilitating disease. We look forward to working with the EMA to complete the review process."
Krystexxa became commercially available in the United States by prescription on December 1, 2010, and is the only FDA approved product specifically indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors, at the maximum medically appropriate dose or for whom these drugs are contraindicated. Krystexxa is not recommended for the treatment of an elevation of blood concentration of uric acid that is not accompanied by signs or symptoms of gout, a condition referred to as asymptomatic hyperuricemia.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing Krystexxa (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to Krystexxa and its uses from Duke University (Duke) and Mountain View Pharmaceuticals, Inc. (MVP).