The FDA granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. Developed by Chemo Research S.L., it is the first treatment approved in the U.S. for the treatment of Chagas disease, a parasitic infection, and the company was also awarded a tropical disease priority review voucher following the approval.
The FDA previously granted benznidazole priority review and an orphan product designation. Benznidazole was evaluated in two placebo-controlled clinical trials in patients 6 to 12 years old. In the first trial, approximately 60 percent of children treated had an antibody test change from positive to negative compared to approximately 14 percent with placebo.
The second trial saw approximately 55 percent with benznidazole compared to 5 percent with placebo. An additional study of safety and pharmacokinetics in pediatric patients 2 to 12 years of age provided information for dosing recommendations down to 2 years of age, the agency said.