The FDA granted ages 2 to 12 years, making it the first treatment approved in the U.S. for the condition.
Approval was based on findings from two placebo-controlled studies in kids ages 6 to 12, both of which found a significantly larger portion of kids treated with the drug had an antibody test change from positive to negative (60% versus 14% and 55% versus 5%).
An additional safety and pharmacokinetic study of kids ages 2 to 12 led to approval in younger patients, the agency said. The drug is manufactured by the Spanish firm Chemo Research S.L.
Benznidazole was one of two drugs, along with nifurtimox, that the CDC has made available for antiparasitic treatment . Historically, the drug has only been produced by a , but Chemo Research to develop the drug in the U.S.
Chagas, also known as American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through various routes including contact with feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. After years of infection, the disease can cause cardiomyopathy.
, published in the New England Journal of Medicine, found that while it reduced serum parasite detection, it didn't significantly reduce cardiac clinical deterioration over 5 years of follow-up.
The most common adverse reactions with benznidazole were stomach pain, rash, decreased weight, headache, nausea, vomiting, abnormal white blood cell count, urticaria, pruritus, and decreased appetite. The drug is associated with serious risks including skin reactions, nervous system effects, and bone marrow depression, the FDA said.
While Chagas primarily affects people living in rural parts of Latin America, recent estimates have suggested that there may be some 300,000 people in the U.S. living with the condition, according to the agency.
FDA had granted benznidazole priority review and orphan product designation, and Chemo Research was also given a tropical disease priority review voucher along with the approval.