The FDA has approved Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients.

Lampit, an oral, antiprotozoal medication, is for newborns to patients less than 18 years old, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi. Delivery is through a dividable tablet that can be split by hand. The tablet is formulated to disperse in water for patients with difficulty swallowing whole or halved tablets.

According to the WHO, there are between 6 million and 7 million people infected with Chagas disease (American Trypanosomiasis) globally. The illness can be acute or chronic. Symptoms include fever, fatigue, body aches, swollen glands and enlargement of the liver or spleen.

“Chagas disease is mainly endemic in areas of 21 continental Latin American countries, where it is mostly … transmitted to humans by contact with feces or via the urine of triatomine bugs, known as ‘kissing bugs,’ among many other popular names, depending on the geographical area,” the organization said.

Lampit’s approval is based on a prospective, randomized (to dosing regimen), double-blind phase III study of the efficacy, safety and pharmacokinetics of nifurtimox in 330 male and female children with Chagas disease at 25 sites in Argentina, Bolivia and Colombia between 2016 and 2018.

More than 300 patients with serologic evidence of T. cruzi infection, without Chagas disease-related cardiovascular and/or gastrointestinal symptoms, were randomly assigned to receive either a 60-day (n=219) or a 30-day (n=111) treatment regimen. The primary outcome measures were the percentage of cured patients at 12 months post-treatment and the incidence rate of seronegative conversion for subjects receiving at least one dose of the 60-day nifurtimox regimen.

The results showed superiority in favor of the nifurtimox 60-day arm compared to the nifurtimox 30-day arm. The study will continue with a second part that includes patient follow-up.

Leverkusen, Germany-based Bayer said commercially insured patients may qualify for a $0 copay and uninsured patients who cannot afford the treatment may be eligible to receive it free through the Bayer U.S. Patient Assistance Foundation.

There are others developing Chagas disease treatments, including San Diego’s Selva Therapeutics Inc, which raised $3 million in a series A financing in late July. The company is driving SLV-213, a broad-spectrum antiviral for infectious diseases that include Chagas but also Ebola and Nipa viruses.

In April, Daiichi Sankyo Daiichi Sankyo renewed a joint research agreement with the Drugs for Neglected Diseases initiative for a new research program, the Lead Optimization Project, to develop treatments for Chagas disease. This project is funded through the Global Health Innovative Technology Fund.