Savient Pharmaceuticals, Inc. announced that it has, through its wholly owned subsidiary, Savient Pharma Ireland Limited, delivered via courier to the European Medicines Agency (EMA) and the assigned co-rapporteurs, the Marketing Authorization Application (MAA) for Krystexxa (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Currently there are no EMA approved treatments for this condition available in the European Union.
Savient's MAA delivery was timed to meet the EMA's designated May 6, 2011 submission date. The MAA submission will be reviewed under the EMA centralized licensing procedure for member states of the European Union, and the application includes clinical and safety data from Savient's pivotal phase 3 studies and the Open Label Extension programme of Krystexxa.
"We remain committed to advancing care for patients who suffer from this devastating disease and the MAA submission for Krystexxa demonstrates an important step forward in addressing a significant unmet medical need that currently exists in Europe," stated John H. Johnson, chief executive officer of Savient. "While Krystexxa is currently available in the United States, this submission reflects our belief that Krystexxa will have a very important role in the future management of refractory chronic gout globally."
Krystexxa became commercially available in the US 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").