FDA OKs First Chagas Disease Drug in U.S.

Aug 31, 2017

The U.S. FDA granted accelerated approval to benznidazole for use in children ages 2 to 12 with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease, which affects about 300,000 people in the U.S.

Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy, FDA says. After many years, it can cause serious heart illness and affect swallowing/digestion.

Benznidazole was approved using the Accelerated Approval pathway, which allows the FDA to approve drugs for serious conditions where there is unmet medical need and adequate and well-controlled trials establish that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe the anticipated clinical benefit of benznidazole.