Posted by Michael Wonder on 29 Aug 2017
FDA approves first U.S. treatment for Chagas disease
29 August 2017 - The U.S. FDA today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease.
It is the first treatment approved in the United States for the treatment of Chagas disease.
The safety and efficacy of benznidazole were established in two placebo-controlled clinical trials in paediatric patients 6 to 12 years old. In the first trial, approximately 60 percent of children treated with benznidazole had an antibody test change from positive to negative compared with approximately 14 percent of children who received a placebo. Results in the second trial were similar: Approximately 55% of children treated with benznidazole had an antibody test change from positive to negative compared with 5 percent who received a placebo. An additional study of the safety and pharmacokinetics (how the body absorbs, distributes and clears the drug) of benznidazole in paediatric patients 2 to 12 years of age provided information for dosing recommendations down to 2 years of age.
