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news.The European Medicines Agency (EMA) has validated Savient Pharma Ireland's Krystexxa (pegloticase) marketing authorization application (MAA).
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Krystexxa is indicated as a treatment for chronic gout in adult patients refractory to conventional therapy.
The MAA was submitted on the basis of safety and efficacy data from Savient’s pivotal Phase 3 and open label extension studies of Krystexxa, as well as detailed information on non-clinical studies and chemistry, manufacturing and control of production.
Savient has licensed rights to the technology related to Krystexxa and its uses from Duke University (Duke) and Mountain View Pharmaceuticals (MVP).