FDA approves first U.S. treatment for Chagas disease

The US Food and Drug Administration (FDA) announced yesterday that it has granted accelerated approval for the nation’s first treatment for Chagas disease, a parasitic infection caused by Trypanosoma cruzi spread by kissing bugs that has increasingly been found in the United States, especially in Texas’s Rio Grande Valley area.

The drug benznidazole, made by Chemo Research, SL, of Madrid, is approved for use in children ages 2 to 12 years old who have Chagas disease. Its safety and efficacy were shown in two placebo-controlled clinical trials in children 6 to 12 years old. An additional study in kids ages 2 to 12 helped set dosing recommendations. Stomach pain, rash, decreased weight, and headache were among the most common adverse reactions, and the drug was associated with some serious risks, including skin reactions, nervous system effects, and bone marrow depression. 

Though the accelerated approval pathway allows the FDA to clear the way for drugs for serious conditions where there are unmet medical but clinical studies show reasonably likely clinical benefits, more studies are needed to verify and spell out benznidazole’s clinical benefits.

Edward Cox, MD, who directs the FDA’s office of antimicrobial products in its Center for Drug Evaluation and Research, said in the statement, “The FDA is committed to making available safe and therapeutic options to treat tropical diseases.” 

A recent estimate suggests about 300,000 people in the United States are infected with the parasite. Nearly a third of the people sickened by Chagas can develop potentially fatal cardiomyopathy.

In the Pharmacist

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