BRIEF—Lampit gets FDA nod for Chagas disease in children

The US Food and Drug Administration has approved Lampit 00(nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).

Developed by Germany’s Bayer, Lampit, an antiprotozoal medication, will be available in a new, dividable tablet that can be split on the scored lines by hand.

This indication is approved under accelerated approval 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 two different IgG antibody tests against antigens of T. cruzi.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Bayer is working to ensure access to the drug for all patients through retail channels.

Commercially insured patients may qualify for a $0 co-pay to help with their out-of-pocket costs.

For uninsured patients who cannot afford Lampit, the Bayer US Patient Assistance Foundation, a charitable organization, will help eligible patients obtain the prescription medication at no cost.