EMA Backs Single-Dose Acoziborole for Gambiense Sleeping Sickness Outside EU

Overview

• The EMA’s CHMP adopted a positive scientific opinion on February 24 for Acoziborole Winthrop under Article 58 via the EU-M4all accelerated assessment.
• Acoziborole is given as a single oral dose effective across both stages of g-HAT, eliminating the need for lumbar puncture and hospitalisation.
• In a Phase II/III study in the Democratic Republic of Congo and Guinea (208 participants), treatment success at 18 months was about 95% in second-stage disease and 100% in first and intermediate stages.
• The medicine is indicated for adults and adolescents aged 12 years and older weighing at least 40 kg, with common side effects including headache, fever, weakness, decreased appetite and tremor, and it is contraindicated in some heart rhythm conditions and with certain HIV and other medicines.
• EMA says the opinion will support WHO prequalification and country approvals, and Sanofi says it will donate the drug via WHO so patients receive it free of charge.