Xuriden (uridine triacetate) filed with FDA as antidote to 5-fluorouracil-Wellstat Therapeutics

Wellstat Therapeutics’ new drug application (NDA) for Xuriden (uridine triacetate) has been accepted for review by the FDA as an antidote. The NDA seeks FDA approval of uridine triacetate as treatment for patients at risk of serious toxicity following an overdose of the chemotherapy agent 5-fluorouracil (5-FU) and patients exhibiting symptoms of serious toxicity within 96 hours of 5-FU administration. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2016.

Comment: Used in combination with other drugs or radiation, 5-FU is a mainstay of chemotherapy across a variety of solid tumors, including those of the colon, stomach, esophagus, breast, pancreas and head and neck.