EMA to review fexinidazole for sleeping sickness

31 January 2018

French pharma major Sanofi (Euronext: SAN) has asked the European Medicines Agency 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.

The EMA has accepted the application under a special procedure called "Article 58" which allows the Agency to give a scientific opinion, in cooperation with the World Health Organization, 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.

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