CHMP recommends approval of fexinidazole for sleeping sickness.- Sanofi.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of fexinidazole, from Sanofi, the first all-oral treatment that has been shown to be efficacious for both stages of sleeping sickness.

During the clinical trials, which enrolled 749 patients in the DRC and Central African Republic, fexinidazole showed high efficacy and safety in both stages of the disease, both in adults and children of at least 6 years old and weighing at least 20 kg. Results showed that fexinidazole could, therefore, eliminate the need for systematic hospitalization and potential reduction in number of lumbar punctures.

Fexinidazole is indicated as a 10-day once-a-day treatment for Trypanosoma brucei gambiense sleeping sickness (the most common form of the disease, found in West and Central Africa). Importantly, fexinidazole is the first all-oral treatment that works both for (i) the early stage of the disease as well as the (ii) second stage of the disease in which the parasites have crossed the blood-brain barrier, causing patients to suffer from neuropsychiatric symptoms.The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.