FDA approves Chemo's Chagas treatment

FDA granted accelerated approval to benznidazole from the Chemo Research S.L. unit of Chemo Group (Barcelona, Spain) to treat Chagas disease caused by Trypanosoma cruzi in children ages 2-12. FDA said the nitroimidazole antimicrobial is the first approved Chagas treatment in the U.S. In conjunction with the approval, the company will receive a tropical disease Priority Review voucher. Benznidazole has Orphan Drug status in the U.S.

Chemo said benznidazole will be available "in the next few months" and that a full 60-day treatment course is expected to cost less than $950, and potentially less than $50 under a patient assistance program...