Lampit Approved to Treat Chagas Disease

August 7, 2020 – The U.S. FDA has approved Lampit® (nifurtimox), manufactured by Bayer, to treat pediatric patients who weigh at least 2.5kg (5.5 pounds) and have Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).

Affecting an estimated 300,000 people in the United States, Chagas disease is a type of protozoan infection. It is endemic throughout much of Mexico, Central America, and South America, with affected individuals in the United States typically having emigrated from these areas. T. cruzi, the organism responsible for the infection, is spread to humans by a type of bug known as triatomines, or kissing bugs, that thrive in settings where homes are made of mud walls and thatched roofs. Chagas disease can also be spread via blood transfusion, organ transplant, congenital transmission, and, in rare cases, through lab accidents or food and drink. Up to 20% of patients chronically infected with Chagas disease will go on to have symptoms that may include cardiovascular disease and gastrointestinal problems.

Lampit was granted accelerated approval based on the number of treated patients who became immunoglobulin G (IgG) antibody negative for Chagas disease or who showed a decrease of at least 20% in optical density on two different IgG antibody tests against antigens of T. cruzi. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Recommended dosing is based on the patient’s weight. Lampit is taken three times a day with food for 60 days. The tablets are specially designed to split by hand if only half a tablet is needed for the proper dose. They should not be cut using a pill-cutter or similar device. If needed, Lampit 30mg and 120mg tablets can be made into a slurry for patients who cannot swallow tablets.

Launch and pricing plans are not yet available.