FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Benznidazole

Indication:

Treatment of children aged 2-12 years with Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. Additionally, the CDC recommends antiparasitic treatment for all cases of acute (ie, congenital) or reactivated Chagas disease and for chronic T cruzi in children up to age 18 years. The CDC also strongly recommends treatment for adults aged 50 years or younger with chronic infection who do not already have advanced Chagas cardiomyopathy.

Mechanism:

Nitroimidazole antimicrobial. Generates radical species in both aerobic and anaerobic conditions that are capable of damaging parasitic DNA. Inhibits DNA, RNA, and protein synthesis within the T cruzi parasite.

Dosage, prescribing information:

2-12 years: 5-8 mg/kg/day PO divided in 2 doses separated by about 12 hr x 60 days

Dosage, CDC guidelines:

<12 years: 5-7.5 mg/kg/day PO divided in 2 doses separated by about 12 hr x 60 days

≥12 years: 5-7 mg/kg/day PO divided in 2 doses separated by about 12 hr x 60 days

Approval:

Approval was based on 2 placebo-controlled clinical trials in children aged 6-12 years. In the trials, approximately 55-60% of children treated with benznidazole had an antibody test change from positive to negative, compared with approximately 5-14% who received placebo. An additional study of the safety and pharmacokinetics of benznidazole provided information for dosing recommendations in children as young as 2 years.

Reference:

Benznidazole prescribing information. Exeltis USA, Inc. Florham Park, NJ. August, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209570lbl.pdf

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