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news.Savient Pharmaceuticals has filed marketing authorization application (MAA) with the European Medicines Agency (EMA) for its chronic gout treatment Krystexxa (pegloticase) in adult patients refractory to conventional therapy, through its subsidiary Savient Pharma Ireland.
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The MAA includes clinical and safety data from Savient‘s pivotal Phase 3 studies and the Open Label Extension program of Krystexxa.
Savient Pharma CEO John Johnson said they 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.
"While Krystexxa is currently available in the US, this submission reflects our belief that Krystexxa will have a very important role in the future management of refractory chronic gout globally," Johnson said.