Lampit FDA approval : Bayer has bagged approval for its antiprotozoal medication Lampit (nifurtimox) from the US Food and Drug Administration (FDA) for the treatment of Chagas disease in pediatric patients, from newly born to less than 18 years of age, weighing at least 2.5kg.
Chagas disease is an infectious tropical disease caused by Trypanosoma cruzi (T. cruzi) parasite.
Lampit is now the only Chagas disease drug to be approved in the US for use in pediatric patients.
According to Bayer, Lampit will be available in a new, dividable tablet that can be split on the scored lines by hand. As per the prescribing instructions, the tablet is formulated specially to disperse in water, which can help in the dosing and administration to pediatric patients who could find it difficult in swallowing full or half tablets, said the German pharma giant.
Bayer said that the indication has been approved under the FDA accelerated approval based on the number of patients treated with the antiprotozoal medication who became immunoglobulin G (IgG) antibody negative or who showed a minimum of 20% reduction in optical density on two different IgG antibody tests against antigens of T. cruzi.
Continued approval for the indication could be subject to verification and description of clinical benefit in one ore more confirmatory trials, said Bayer.
Commenting on Lampit FDA approval, Aleksandra Vlajnic – senior vice president and head of Medical Affairs for the Americas at Bayer, said: “Chagas disease can strike at any age, and early detection and treatment are important. This is especially relevant for children.
“The importance of treating children is a major reason behind Bayer’s collaboration with health authorities to enhance access to Lampit as a means to provide treatment for Chagas disease.”
The Lampit FDA approval has been granted by the FDA on the findings of the ‘Chagas disease in children treated with nifurtimox study’, which is the first part of a phase III program in pediatric patients with Chagas disease. Bayer said that the trial will continue with a second part, called Lampit SECURE, for following up of patients for an additional three years to confirm the efficacy and safety of the antiprotozoal medication.