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.
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