EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of sleeping sickness (rhodesiense)

ACCESS TO HEALTHCARE • February 9, 2024

Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment, and is transmitted by the bite of infected tsetse flies, which are found in 36 African countries. In December 2023, Sanofi, DNDi and the HAT-r-ACC consortium announced the CHMP (EMA) has adopted a positive scientific opinion of Fexinidazole Winthrop for the treatment in patients 6 years of age or older of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness. A positive opinion of both stages of the more common form (T.b. gambiense, found in West and Central Africa) was adopted in 2018.

This second positive opinion demonstrates Sanofi’s 23 year commitment to develop innovative therapies to fight sleeping sickness and paves the way for updated WHO guidelines on the treatment of the T.b. rhodesiense form of sleeping sickness. Once the guidelines are updated, Foundation S, Sanofi’s philanthropic organization will donate Fexinidazole Winthrop to the World Health Organization.

Sanofi is committed to contribute to the elimination of sleeping sickness by 2030, supporting the WHO Neglected Tropical Diseases roadmap.

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