The FDA on Tuesday approved Chemo Research's Chagas drug for use in children ages 2 to 12.
Chagas disease, also called American trypanosomiasis, is an inflammatory infectious disease caused by the parasite Trypanosoma cruzi. If left untreated, Chagas disease can cause serious heart and digestive problems.
Here are three things to know.
1. The drug, benznidazole, was approved using the FDA's Accelerated Approval Pathway.
2. The drug displayed efficacy in two separate clinical trials in pediatric patients. In both trials, 55 percent to 60 percent of children treated with benznidazole tested negative for the disease post treatment.
3. Benznidazole is the first FDA-approved Chagas disease treatment in the U.S.