The U.S. Food and Drug Administration today approved Anascorp, an antivenom produced in Mexico and tested in clinical trials conducted through the University of Arizona, for use in treating patients suffering the effects of scorpion sting.
"This is a historic event," said Dr. Leslie Boyer, director of the UA's VIPER Institute (Venom Immunochemistry, Pharmacology and Emergency Response Institute) and lead investigator on the clinical trials. "This is the first-ever drug approved for this use by the FDA; the first-ever drug that we are aware of being developed fully in Latin America and subsequently approved by the FDA; the first-ever scorpion antivenom proved effective under controlled clinical trials; and the first-ever antivenom with so few allergic reactions."
Nearly 2,000 patients in Arizona and Nevada have received the antivenom through the clinical trials conducted by Boyer, a pediatrician and toxicologist at the UA College of Medicine, and her colleagues.
Ultimately, these clinical trials brought together 27 Arizona hospitals, one hospital in Nevada and hundreds of volunteer health-care professionals, creating a first-of-its-kind outreach study network capable of conducting clinical trials of a treatment for a rare emergency.
The FDA approval is the culmination of a nearly 12-year collaboration of academic and clinical researchers with partners in business and industry from both sides of the U.S.-Mexico border. The benefits of this cooperative, international effort extend beyond U.S. patients.
Dr. Alejandro Alagn from the Institute of Biotechnology of the UNAM (National Autonomous University of Mexico) is an antivenom researcher, an adviser to Instituto Bioclon and an associate investigator at the UA VIPER Institute.
"We have been working together to test the Mexican antivenom under United States rules for close to 12 years, learning a lot from the process and learning from each other. This collabora
|Contact: Ann Cisneros|
University of Arizona Health Sciences Center