BTG plc of London said that Wellstat Therapeutics’ new drug application for uridine triacetate has been accepted for review by FDA.
The sponsor seeks approval of uridine triacetate as treatment for patients at risk of serious toxicity following an overdose of the chemotherapy agent 5-fluorouracil and patients exhibiting symptoms of serious toxicity within 96 hours of 5-FU administration.
FDA has provided an anticipated Prescription Drug User Fee Act action date in March 2016. Uridine triacetate is being developed by Wellstat Therapeutics. If approved by FDA, BTG will market, sell and distribute uridine triacetate for this indication in the US. Wellstat Therapeutics retains certain rights to exercise an option to co-promote uridine triacetate. Terms of the co-promote have not been disclosed.
In 2009, uridine triacetate received orphan drug designation from FDA as an antidote in the treatment of 5-fluorouracil poisoning and from the European Medicines Agency as a treatment for 5-fluorouracil overdose. Under an expanded access protocol, FDA emergency treatment provisions in the US, and similar emergency use provisions in Europe and the rest of the world, 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. The NDA for uridine triacetate is based in part on efficacy and safety data from U.S. sites in this protocol.
Published literature suggests that each year, approximately 250,000 to 300,000 patients in the US receive multiple treatments with 5-FU, of which 0.5 percent die from 5-FU toxicity. An estimated 10-20 percent of those patients develop serious, sometimes life threatening, 5-FU toxicity or experience an overdose. Non-fatal 5-FU toxicities can result in hospitalization, intensive care utilization and delays in or discontinuation of chemotherapy.
Uridine triacetate is converted in the body to uridine, a direct biochemical antagonist of 5-fluorouracil toxicity.
