Posted by Michael Wonder on 02 Feb 2020
Bayer application for nifurtimox to treat paediatric patients with Chagas disease submitted for approval in US
30 January 2020 - Submission based on results of CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study of nifurtimox in pediatric patients with Chagas disease as well as pre-clinical data.
On the occasion of the first “World Neglected Tropical Diseases Day”, Bayer reiterates its commitment to contribute to fight these diseases that still threaten 1.5 billion people worldwide. In addition to supporting the World Health Organization with medicines for African sleeping sickness and Chagas disease free of charge, Bayer developed a new formulation of its medication nifurtimox in order to improve the body-weight adjusted dosing in pediatric Chagas patients.
The application to the U.S. FDA builds on the positive results from the CHICO phase III clinical study, the largest clinical study to date in pediatric patients with Chagas disease.
