EMA gives positive opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa

15 December 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of the use of Fexinidazole Winthrop as first oral treatment for T.b. rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. The trial for treatment of T.b. rhodesiense with Fexinidazole Winthrop in Malawi and Uganda was supported by EDCTP through the HAT-r-ACC consortium.

“We congratulate the HAT-r-ACC consortium for their tireless efforts to deliver this well conducted clinical trial and are thrilled with the positive opinion by CHMP.””

Dr Michelle Helinski, EDCTP Senior Project Officer for Neglected Infectious Diseases

“EDCTP is committed to improving the well-being of all people affected by infectious diseases. We celebrate this important milestone with a better treatment option for this truly neglected disease.”

Dr Michael Makanga, Executive Director of the Global Health EDCTP3 programme

This positive opinion is for the treatment in adults and children six years of age or older and weighing at least 20 kg of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness.

Fexinidazole Winthrop is indicated as a 10-day once-a-day oral treatment for T.b. rhodesiense. The treatment has already been registered in the Democratic Republic of Congo (DRC) and Uganda as a treatment for T.b. gambiense, and is recommended for use in a further 10 African countries (Angola, Burkina Faso, Central African Republic, Chad, Congo, Côte d’Ivoire, Equatorial Guinea, Gabon, Guinea, and South Sudan). The CHMP opinion today paves the way for the update of World Health Organization (WHO) guidelines on sleeping sickness, as well as the extended indication and distribution of fexinidazole in African countries where T.b. rhodesiense is prevalent.

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