EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment

Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Sanofi’s (NASDAQ: SNY) Fexinidazole Winthrop (fexinidazole) as a 10-day treatment for acute sleeping sickness caused by Trypanosoma brucei (T.b.) rhodesiense in both adults and children. The EMA is currently evaluating data from a Phase II/III clinical trial conducted in collaboration with the Drugs for Neglected Diseases initiative (DNDi) in Eastern and Southern Africa, regions where this potentially fatal parasitic disease is prevalent.

In 2018, Fexinidazole received similar endorsement from the CHMP for treating the more common form of sleeping sickness caused by T.b. gambiense, which is typically found in West and Central Africa.

Sleeping sickness, scientifically known as human African trypanosomiasis (HAT), manifests through symptoms such as aggressiveness, psychosis, disrupted sleep patterns, and can ultimately lead to death.- Flcube.com

Fineline Info & Tech