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US Now Has an Approved Treatment for Chagas Disease

US Now Has an Approved Treatment for Chagas Disease

Sep 08, 2017PAO-M09-17-NI-012

When left untreated, Chagas Disease can lead to heart failure.

Caused by the parasite Trypanosoma cruzi and transmitted by the triatomine bug, Chagas disease, also known as American trypanosomiasis, is a public health concern in the United States, according to the Drugs for Neglected Diseases Initiative (DNDi). If not detected and treated in its early stages, Chagas disease can lead to serious and sometimes fatal heart damage.

Over 1% of Latin-born residents of Los Angeles County, California were found in a recent study to have Chagas disease, and less than 1% of those with the infection were receiving treatment," according to study author Sheba Meymandi, MD, director of the Center of Excellence for Chagas Disease at the Olive View-University of California Los Angeles Medical Center.  Meanwhile, the U.S. Centers for Disease Control and Prevention estimates that approximately 300,000 people across the US have the disease.

"Without treatment, many Chagas patients are at risk of a 'silent death' due to heart failure," Meymandi said in a DNDi news release. "Our study demonstrates the need for similar research in other states, and underscores the critical importance of early detection and treatment to tackle this public health challenge in the U.S." 

The good news is a new FDA-approved treatment (http://www.empr.com/news/chagas-benznidazole-trypanosoma-cruzi-parasite-american-trypanosomiasis/article/685203/) will soon be available for people suffering from Chagas disease. The new drug - benznidazole from Chemo Research – received Priority Review and Orphan Product designations and accelerated approval from FDA and is the first treatment for Chagas disease in the US. It is indicated for children aged 2-12 that have been diagnosed with Chagas disease.

The agency based its approval decision on the results of two placebo-controlled trials in patients aged 6–12 years and a separate safety and pharmacokinetics study of benznidazole in patients aged 2–12 years. In the two trials, approximately 60% and 55% of children who received benznidazole had an antibody test change from positive to negative 

"The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.  

 

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