EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa Paris, Geneva and Nairobi....
Dec 15 (Reuters) - French healthcare company Sanofi (SASY.PA) on Friday said the European Medicines Agency (EMA) had issued a positive opinion of its treatment for sleeping sickness, also called rhodesiense.
The US Food and Drug Administration announced it has approved the therapy, fexinidazole, for the treatment of African Trypanosomiasis, which is commonly known as Sleeping Sickness.
CHMP recommends first oral-only treatment for sleeping sickness
Meeting highlights from Committee for Medicinal Products for Human Use 12-15 Nov, 18
The EMA has offered its endorsement for fexinidazole, which is billed as the first all-oral drug for sleeping sickness.
Sanofi has asked European regulators to review an experimental medicine being developed in partnership with the Drugs for Neglected Disease initiative (DNDi) for sleeping sickness, which is endemic in Africa.
Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). It would be the first all-oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness. It is hoped that this treatment will contribute to the elimination of the disease.