New Sleeping Sickness Pill Gets Nod, Paving the Way for Use in Africa
European regulators endorsed acoziborole, a single-dose oral treatment with up to 96% success at 18 months, improving access and simplifying care for gambiense sleeping sickness.
- Recently, the European Medicines Agency's CHMP granted a positive opinion to Acoziborole as a single‑dose oral treatment for gambiense sleeping sickness, based on phase 2/3 trials.
- Developed by DNDi and Sanofi, phase 2/3 studies in the DRC and Guinea showed up to 96 success at 18 months, underpinning the recommendation.
- The three‑pill, one‑time dose allows home administration, improving access compared to current treatments requiring a 10‑day course, and Sanofi pledged to donate doses to WHO so patients receive it free.
- The CHMP's positive opinion is a critical regulatory step that could help facilitate approval and guideline updates, potentially accelerating progress toward WHO's 2030 goal, experts say.
- Fewer than 600 cases were reported in 2024, but researchers warn that parasite reservoirs remain uncertain and further studies, including trials in children ages one to 14, are under way.
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Africa: Single-Dose Treatment for Sleeping Sickness Receives Approval
[Drugs for Neglected Diseases initiative (DNDi)] Kinshasa / Paris / Geneva / Amsterdam -- · Recommendation based on Phase II/III study demonstrating up to 96 per cent success rates at 18 months across both early and advanced stages of T.b. gambiense, the most common form of sleeping sickness
Can new pills end sleeping sickness?
European drug regulators on Friday endorsed a new and simpler treatment for sleeping sickness, in what could be a giant boost to efforts to eliminate the disease. A European Medicines Agency committee gave its nod to acoziborole, developed by Sanofi and DNDi. Speaking to France 24, Dr Luis Pizarro, executive director of DNDi, said the new pill could revolutionise treatment of the disease, which has killed hundreds of thousands across Africa.
New sleeping sickness pill gets nod, paving the way for use in Africa
European drug regulators are endorsing a new and simpler treatment for sleeping sickness, in what could be a giant boost to efforts to eliminate the disease.
Press Release: Acoziborole Winthrop, developed by DNDi and Sanofi, receives CHMP positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness
A new therapy, given as a single dose of three tablets, could offer a simpler alternative to longer, more complex regimens for sleeping sickness. ...
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