The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Acoziborole Winthrop, an oral treatment for gambiense sleeping sickness developed through a collaboration between Drugs for Neglected Diseases initiative (DNDi) and Sanofi. The approval recommendation marks a significant advancement in addressing human African trypanosomiasis, a parasitic disease endemic to sub-Saharan Africa.
Acoziborole Winthrop represents a substantial simplification in treatment protocols, as a three-tablet, single-dose regimen compared to multi-day treatment courses required by existing therapies. Clinical data presented to the CHMP demonstrated efficacy rates of up to 96% at 18 months post-treatment. The streamlined administration approach is expected to improve treatment completion rates and reduce patient burden in resource-limited settings where the disease primarily affects populations.
Following the positive opinion, Sanofi has committed to donating the medicine to the World Health Organization for distribution in endemic countries. The regulatory endorsement supports WHO's strategic objective to eliminate gambiense sleeping sickness as a public health threat by 2030. Final approval from the European Commission is anticipated to follow the CHMP recommendation, enabling broader access to the treatment across affected regions.