FDA approves Wellstat’s Vistogard for chemotherapy overdose
The US Food and Drug Administration (FDA) has approved Wellstat Therapeutics’ Vistogard (uridine triacetate) to treat overdose of fluorouracil or capecitabine, which are administered for several malignancies.
Vistogard is claimed to be the first antidote for emergency treatment of 5-fluorouracil (5-FU) overdose treatment available to patients.
It is also indicated for patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or those who experience severe adverse reactions within 96 hours following the end of 5-FU or capecitabine administration.
The approval is based on data from a development program in 135 patients, which demonstrated the efficacy and safety of a single course of Vistogard 10mg given orally every 6 hours in 20 doses.
Study data demonstrated that overall survival of patients with 5-FU toxicity who received Vistogard was 96%, when compared to 16% in historical cases that used standard supportive measures.
Patients treated with Vistogard resumed chemotherapy sooner, with 33% restarting treatment within 30 days.
Vistogard is not recommended to treat non-emergency adverse reactions related with flourouracil or capecitabine as it may reduce the efficacy of those drugs.
Wellstat Therapeutics CEO Samuel Wohlstadter said: “Wellstat has developed Vistogard to help patients treated with 5-FU or capecitabine who develop severe or life threatening toxicity or experience an overdose.
“It is the only treatment approved by the FDA for early onset severe toxicities or 5-FU overdose and now will be available to the thousands of patients impacted by this condition.”