NDA for 5-FU Overdose Antidote Accepted for Review

Wellstat Therapeutics has announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for uridine triacetate as an antidote for patients at risk of serious toxicity following an overdose of 5-fluorouracil (5-FU), and patients who exhibit serious toxicity within 96 hours of being treated with 5-FU.

Overexposure to 5-FU can occur if the drug has been administered at a dose or rate greater than intended, or when a patient has genetic variations, impaired clearance or other biochemical factors that increase sensitivity to the drug. Serious, sometimes life-threatening, 5-FU toxicity has occurred in an estimated 10-20% of patients treated with 5-FU. Administration of uridine triacetate can reduce the ability of toxic 5-FU metabolites to incorporate into the genetic material of healthy cells, enabling cellular recovery after overexposure to 5-FU and preventing cell death.

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In 2009, the FDA granted uridine triacetate Orphan Drug status as an antidote for 5-FU poisoning. Under an expanded access protocol and under FDA emergency treatment provisions, uridine triacetate is currently provided to patients at risk of excess 5-FU toxicity due to overdose and patients exhibiting serious toxicities to 5-FU within 96 hours of 5-FU administration.

For more information call (240) 631–2500 or visit WellstatTherapeutics.com.

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