Sanofi says EMA gives positive opinion of Fexinidazole Winthrop for rhodesiense

Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness, rhodesiense. 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 and second-stage. Trypanosoma brucei rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. Dietmar Berger, Head of Development and Chief Medical Officer, Sanofi, said, “The CHMP’s positive opinion is another step forward in Sanofi’s commitment to help deliver innovative treatments to vulnerable patient communities impacted by sleeping sickness, a deadly neglected tropical disease. By working with WHO and DNDi, we have made tremendous progress in improving treatment outcomes and simplifying treatment delivery. This partnership and our donation of Fexinidazole Winthrop through Foundation S, reflect our mission to provide innovative treatments to patients, no matter where they live.”