Sanofi asks EMA to reviewfexinidazole for the treatment of sleeping sickness.

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. EMA has accepted the application under a special procedure called "Article 58" which allows the EMA to give a scientific opinion, in co-operation with the World Health Organization (WHO), for the evaluation of medicinal products that are intended exclusively for markets outside of the European Union. Fexinidazole was previously granted accelerated assessment by the EMA. Following the evaluation of the dossier, the EMA will publish its scientific opinion of the benefit risk of the treatment, which will facilitate the registration of fexinidazole in HAT-endemic countries.