The positive opinion by EMA is a major milestone after 30 years of research into better treatments for sleeping sickness. (Photo: Olivier Brandenberg/Swiss TPH)
The positive opinion by EMA is a major milestone after 30 years of research into better treatments for sleeping sickness. (Photo: Olivier Brandenberg/Swiss TPH) The European Medicines Agency has adopted a positive opinion of fexinidazole for the treatment of T.b. rhodesiense sleeping sickness, found in Eastern and Southern Africa. The positive opinion is followed a clinical trial conducted by the HAT-r-ACC Consortium, of which Swiss TPH is a part. This is an important milestone in the fight against this acute and lethal form of the neglected tropical disease. 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. This positive opinion is for the treatment of Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. This CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases initiative (DND i ).
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