ARTICLE | Clinical News

Xuriden uridine triacetate regulatory update

September 14, 2015 7:00 AM UTC

FDA approved an NDA from Wellstat for Xuriden uridine triacetate to treat hereditary orotic aciduria, a metabolic disorder the agency said affects about 20 people worldwide. The oral uridine prodrug had been under Priority Review and has Orphan Drug and breakthrough therapy status. FDA based its approval primarily on a 4-patient study in which the drug stabilized prespecified hematologic parameters. Wellstat expects to launch Xuriden early next year. The company has not yet decided on a price.

Wellstat received a Priority Review voucher under FDA’s rare pediatric disease Priority Review voucher program following the approval. Under a 2014 deal, AstraZeneca plc (LSE:AZN, NYSE:AZN, London, U.K.) will gain the voucher for an undisclosed sum. ...