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."
Image: The approval of Wellstat Therapeutics’ Vistogard was based on data from a a development program in 135 patients. Photo: courtesy of Baitong333/FreeDigitalPhotos.net.