August 30, 2017: The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. The authors determined an overall prevalence of Chagas infections in those individuals to be 1.24%, suggesting about 30,000 cases of the disease in Los Angeles County alone.
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 US living with the condition, according to the agency. Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi.
Benznidazole was one of two drugs, along with nifurtimox, that the CDC has made available for antiparasitic treatment under investigational protocols.
Benznidazole, manufactured by Chemo Research SL, was evaluated in 2 placebo-controlled clinical trials in children aged 6 to 12 years.
With this approval, benznidazole's manufacturer, Chemo Research, S. L., is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases. In the first trial, nearly 60% of participants treated with benznidazole had antibody tests change from positive to negative compared with 14% of participants who received placebo.
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The secondary trial reported similar results, with approximately 55% of patients experiencing an antibody tests change from positive to negative, compared with 5% of patients who received placebo.
Information on dosing recommendations for children from 2 to 12 years old was obtained via an additional study assessing the safety and pharmacokinetics of the drug.
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.
However, benznidazole is associated with serious risks including serious skin reactions, nervous system effects and bone marrow depression and can have fatal effects for pregnant women based on findings from animal studies.
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