Single-dose treatment approved for sleeping sickness

3 days ago

A single-dose oral treatment for sleeping sickness, Acoziborole Winthrop, has been recommended for approval by the European Medicines Agency (EMA).
The treatment is for gambiense human African trypanosomiasis (HAT), the most common form in Central and West Africa.
It is recommended for adults and adolescents aged at least 12 years, weighing over 40 kgs.
Approval was issued under the EU-M4all Pathway, aiding regulatory decisions in endemic countries like the Democratic Republic of Congo and Guinea.
Sleeping sickness is transmitted by tsetse flies and is fatal if untreated, with early symptoms like fever and headaches.
Acoziborole was developed by Sanofi in partnership with DNDi, offering a simpler alternative to previous treatments like NECT and fexinidazole.
Phase II/III trial data showed a 96% success rate at 18 months for early and late-stage disease.
WHO aims to eliminate gambiense sleeping sickness by 2030, with this treatment seen as critical for surveillance in declining case numbers.
Sanofi will donate the treatment through Foundation S, ensuring free provision in endemic countries.
A study is underway in the DRC and Guinea to evaluate the drug in children aged 1 to 14 years.

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