FDA approves first US treatment for Chagas disease

The US Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages two to 12 years old with Chagas disease. It is the first treatment approved in the USA for the treatment of Chagas disease.

With this approval, benznidazole’s manufacturer, Spain-based Chemo Research, is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” said Dr Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.