Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient Pharma Ireland Limited, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA® (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. This opinion will be transmitted to the European Commission, which has the authority for granting marketing authorisations in the EU. If such marketing authorization is granted, KRYSTEXXA will address a significant unmet medical need for certain patients with refractory chronic gout (RCG) in the European Union.
"This is a major milestone in our ongoing commitment to advance care for patients who suffer from this burdensome and debilitating disease. The CHMP's positive opinion marks an important step forward in addressing the significant unmet medical need that currently exists in Europe; and we look forward to receiving the final decision from the European Commission," said Louis Ferrari, President and Chief Executive Officer of Savient.
The positive CHMP opinion was based upon a detailed evaluation of the Marketing Authorization Application (MAA), which included safety and efficacy data from Savient's two pivotal Phase III studies, and a long-term open label extension study of KRYSTEXXA, as well as non-clinical and chemistry, manufacturing and control information.