Shots:

• The approval is based on P-III Lampit study assessing nifurtimox in 330 children with chagas disease with serologic evidence of T. cruzi infection in a ratio (2:1) to receive either a 60/ 30 days Lampit treatment regimen- and were followed up for 1yr. after end of treatment. The company continues the study with a second part (Lampit SECURE) to follow patients for an additional 3yrs.to confirm its efficacy and safety
• Results: showed superiority on nifurtimox 60day arm; Lampit reveals adequate antiprotozoal activity in patients aged 0-17yrs. The indication is approved under accelerated approval based on the number of treated patients who became IgG Ab negative or showed an at least 20% decrease in optical density on two different IgG Ab tests against antigens of T. cruzi
• Lampit is an antiprotozoal agent indicated for paediatric patients aged ≤ 18yrs. and weighing at least 2.5kg for Chagas disease and is currently registered in multiple Latin American countries

­ Ref: Drugwatch | Image: Drugwatch