Commentary: Eliminating sleeping sickness could be within reach

What does it mean: The positive opinion comes from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) under the EU-M4all procedure, for the treatment of adults and adolescents aged 12 and older. Following this development, Sanofi can now proceed with filing for registration in low- and middle-income countries (LMICs). 

Access enabler: Sanofi, through its philanthropic arm Foundation S, has previously pledged to donate the medicine free of charge to the World Health Organization (WHO) for distribution in endemic regions, supporting the WHO’s goal of eliminating sleeping sickness by 2030. 

Who stands to benefit: Sleeping sickness primarily affects rural areas of Central and West Africa, with the population of the Democratic Republic of the Congo (DRC) carrying the highest burden. If left untreated, the disease is generally fatal. 

Why is it promising: Acoziborole (Acoziborole Winthrop) simplifies treatment and diagnosis compared to previous therapies: 

• One-day, three-tablet oral regimen replaces multi-day treatments and complex delivery methods. 

• Treats early and advanced stages of disease, reducing the need for invasive diagnostics such as lumbar punctures and complex microscope-based tests to determine the disease stage. 

Continued investment in low-return disease area: Despite limited commercial returns, Sanofi has supported sleeping sickness programmes through sustained investment in research and development and donation initiatives. The company’s collaboration with the Drugs for Neglected Diseases initiative (DNDi), supported by the Gates Foundation, demonstrates how public-private partnerships, long-term investment and coordinated efforts can help address treatment gaps and advance disease elimination in LMICs.  

Reporting on impact: For the first time, Sanofi provided data on sleeping sickness patient reach in its latest environment, social and governance report, showing the scale and effectiveness of its efforts. These figures also help illustrate the company’s impact on eliminating the disease, with donations over the past decade playing a key role in the progress achieved. The Access to Medicine Foundation encourages Sanofi and other companies to maintain this level of transparency and apply the same standard across other disease areas.  

Alignment with the Access to Medicine Index: This announcement links to a recommendation in the 2024 Index for companies to make long-term donation commitments for new pipeline products targeting neglected tropical diseases, helping ensure people in LMICs can access these innovative treatments. With this development, Sanofi’s commitment to donate the medicine free of charge can now move from promise to action. 

Next steps: Following the positive CHMP opinion, the Access to Medicine Foundation anticipates Sanofi to swiftly file for registration in endemic countries, starting with the DRC. The medicine is also being tested in children aged 1-14 years by DNDi, with study completion expected by the end of March 2026. If successful, the Access to Medicine Foundation encourages Sanofi to ensure paediatric access keeps pace with adult treatment, avoiding a delay that is common across the industry. Expanding acoziborole’s (Acoziborole Winthrop) indication would build on one of the most significant advances in sleeping sickness treatment and elimination efforts in decades.