The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of acoziborole Winthrop as a treatment for Trypanosoma brucei gambiense sleeping sickness in adults and adolescents aged 12 and older. The positive opinion represents a significant development in the therapeutic management of this parasitic disease, which remains a major public health concern in sub-Saharan Africa. The recommended regimen consists of a single oral dose administered as three tablets, marking a notable shift in treatment delivery compared to currently available options.
Data from phase 2/3 clinical trials formed the basis of the CHMP recommendation, with the treatment demonstrating success rates of up to 96 percent at the 18-month follow-up assessment. The trial results underscore the efficacy of the acoziborole formulation relative to existing therapeutic approaches, which typically require either 10-day oral regimens or combinations of injectable medications. The simplified dosing schedule may improve patient compliance and reduce the treatment burden associated with sleeping sickness management.
Sanofi, which co-developed acoziborole with Médecins Sans Frontières-affiliated research organization DNDi, has committed to donating the medication to the World Health Organization through its philanthropic foundation. This commitment aligns with global efforts to address neglected tropical diseases and expand access to effective treatments in resource-limited settings where sleeping sickness remains endemic.