Savient Pharmaceuticals (SVNT) and its wholly owned subsidiary, Savient Pharma Ireland, announced that the European Commission has granted a marketing authorization 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. The European Commission's approval decision was based upon 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.
- Pharmaceuticals & Drug Trials
- Savient Pharmaceuticals
- the European Commission