The Food and Drug Administration (FDA) has approved Lampit (nifurtimox; Bayer) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi) in pediatric patients <18 years of age weighing at least 2.5kg.

The accelerated approval of Lampit was based on the number of treated patients who became immunoglobulin G (IgG) antibody negative or who showed an at least 20% decrease in optical density on 2 different IgG antibody tests against antigens of T. cruzi.

Nifurtimox, a nitrofuran antiprotozoal drug, was approved based on data from a prospective, double-blind phase 3 trial conducted in Argentina, Bolivia and Columbia. Pediatric patients (n=330) with serologic evidence of T. cruzi infection and without Chagas disease-related cardiac or gastrointestinal symptoms were randomized 2:1 to a 60-day (n=219) or a 30-day (n=111) treatment regimen and were followed for up to 1 year.

Results showed the nifurtimox 60-day treatment regimen was found to be superior to the 30-day regimen (not an approved dosing regimen) based on serological response. Serological response was defined as a ≥20% decrease in optical density measured by lysate and recombinant ELISA in participants >8 months to <18 years or seroconversion to negative (defined as negative IgG concentration in all patients) at 1-year posttreatment follow-up.

According to Bayer, the study will continue with a second part to follow patients for an additional 3 years to confirm efficacy.

With regard to safety, the most frequently reported adverse reactions included vomiting, abdominal pain, headache, decreased appetite, nausea, pyrexia, and rash. Due to the potential for weight loss, body weight should be checked every 14 days as dosage may need to be adjusted.

Genotoxicity of nifurtimox has been demonstrated in humans. In a study evaluating cytogenetic effect, a 13-fold increase in chromosomal aberrations was observed in pediatric patients with Chagas disease. Prior to treatment, pregnancy testing is recommended as the treatment may cause fetal harm.

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Lampit will be supplied as 30mg and 120mg functionally scored tablets. If divided doses are necessary, the tablets should be split by hand and not with a splitting device. The tablets can also be made into a slurry as an alternative method of administration for patients who cannot swallow.

For more information visit bayer.us.

References

  1. US Food and Drug Administration approves Lampit® (nifurtimox) for the treatment of Chagas Disease in children. https://www.businesswire.com/news/home/20200807005073/en/U.S.-Food-Drug-Administration-Approves-Lampit%C2%AE-nifurtimox. Accessed August 10, 2020.
  2. Lampit (nifurtimox) tablets, for oral use prescribing information. Bayer HealthCare Pharmaceuticals Inc., 2020.