Bayer Lampit has been approved by the FDA for use in pediatric patients.

Lampit is a new, secolytic, dispersable tablet that can be dissodied by hand at the scratch line.
a new formulation that can be easily dispersed in water to help treat pediatric patients who may have difficulty swallowing or need half a tablet.
medication, Lampit can be adjusted according to the patient's weight.
The FDA accelerated approval of Lampit, an adaptation, based on the proportion of patients who had their light density reduced by at least 20 percent in immunoglobulin G (IgG) antibodies trans negative or in two different IgG antibody tests against kerthroid antigens.
approval for the adaptation may depend on the validation and description of the clinical benefits in the validation trial.
chagas disease is an infectious tropical disease that affects about 300,000 people in the United States.
disease is a local disease in most parts of Latin America, but in the United States it is a growing concern for health.
the approval of a drug for use in children is an important milestone.
, senior vice president and head of medical affairs for Bayer Americas, said: "Chagas disease can occur at any age and early detection and treatment is important.
importance of treating children is a major reason for Bayer's cooperation with health authorities, with the aim of increasing access to Lampit as a means of treating Chagas disease.
" FDA approval of Lampit is based on the results of the Phase III CHICO Study (NCT02625974).
This is the first part of the largest phase III clinical treatment phase III project ever undertaken in the chagas disease children's population, and the results confirm the safety and effectiveness of Lampit (easy-to-divide, dispersible, new formulation nifurtimox engraving tablets) in the treatment of pediatric patients with Chagas disease.
CHICO is a forward-looking, randomized, double-blind, historically controlled Phase III study conducted in 2016-2018 at 25 research centers in Argentina, Bolivia and Colombia, involving 330 children with serological evidence of c.K.A. infection (no cardiovascular and/or gastrointestinal symptoms associated with Chagas disease) who were assessed for efficacy, safety, and pharmacodynamics.
study, patients were randomly assigned to a 2:1 scale, received 60 days (n-219) or 30-day (n-111) Lampit treatment, followed for one year after treatment.
results showed that the 60-day Lampit program was superior to the historical placebo control in terms of serological responses followed for one year after treatment, reaching the main endpoint of the study.
across the study group, the 60-day programme has advantages over the 30-day programme (unapproved administration programme) in serological response.
study, Lampit's weight-adjusted dose therapy showed good safety.
the study will continue with Part II (Lampit-SECURE), a three-year follow-up of patients to confirm efficacy and safety.
In fact, the younger the patient, the greater the chance of recovery," said Dr. Jaime Altcheh, co-researcher of the CHICO study and head of parasitology and Chagas disease at Ricardo Gutierrez Children's Hospital in Buenos Aires, Argentina.
new paediatric formula, we can treat newborns and infants more accurately.
this new formulation can be easily split and dissolved in water very quickly, which is especially important because these very young children cannot swallow solid tablets but must be treated three times a day for 60 days.
new formula nifurtimox is a big step towards the goal of treating all infected children.
treatment after infection is important to prevent the performance of adult diseases.
chiCO study, Lampit showed good antigen activity in pediatric patients aged 0-17.
" control of Chagas disease is aimed at eliminating transmission, controlling the vector, treating girls and women of childbearing age (avoiding transmission through the placenta) and testing blood before blood transfusions.
, the aim is to provide medical care to infected persons at all stages of the disease.
treatment for chiagas disease is based on only 2 nitro-ring compounds, nifurtimox and benzznidazole (benzodiaxone).
so far, nifurtimox has been available as only 120 mg tablets, which is difficult to deliver, especially in young children.
has developed a 30 mg tablet.
both pills are now fast-dispersing formulations that can be easily split, and they can quickly dissolve in water to form slurry for patients who have difficulty swallowing the pills.
new formula has been successfully used in CHICO studies, improving dosing accuracy, safety and therapeutic compliance in children of all age groups.
new formula, nifurtimox, will improve the treatment of newborns, infants and children, the most vulnerable group of patients with Chagas disease, and will make a significant contribution to controlling the disease.
disease is caused by trypanosoma cruzi, the main vector of which is schistosomiasis, which was discovered by Dr. Chagas in 1908 and is also known as Chagas disease.
is mainly endemic in Central and South America, so it is also known as South American trypanosomiasis.
is found in human and mammalian blood and in a variety of tissue cells.
there are two forms in the life history of the cone whip hair body and the non-whip hair body.
cone whip hair body through the skin invasive infection into the human blood.
can also be contracted through breast milk, placenta, blood transfusions or food contaminated with infectious conical feces.
estimates that there are 20 million infected people in Central and South America.
most infections are asymptomatic.
cases show only mild flu-like symptoms, which appear directly after infection.
about two months after the attack, Chagas disease entered a chronic phase that lasted for many years, leading to severe organ damage and eventually sudden cardiac death.
, early diagnosis and treatment are key to preventing Chagas disease.
currently, less than 1 per cent of patients infected with Chagas disease are receiving treatment due to lack of awareness of the disease and limited access to treatment.
is committed to expanding access to and use of nifurtimox through new registration applications and the provision of new preparations in countries with higher disease burdens.
original source: U.S. Food and Drug Administration approves ® for the treatment of Chagas Disease in Children.