The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to acoziborole (Acoziborole Winthrop) as a single-dose oral treatment for both early and advanced-stage gambiense sleeping sickness. The three-tablet regimen represents a major advancement over existing therapies that require 10-day courses or injection combinations, with success rates reaching up to 96% across disease stages in Phase 2/3 trials.
Sanofi has committed to donating the medicine through World Health Organization channels at no cost to patients, in partnership with the Drugs for Neglected Diseases initiative. The Democratic Republic of Congo, where the announcement was made, accounts for a large proportion of global sleeping sickness cases.
The approval marks a significant milestone in the effort to eliminate sleeping sickness as a public health problem, offering a dramatically simplified treatment that can reach patients in remote areas where multi-day therapy regimens have historically been difficult to complete.