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Sanofi: fexinidazole submitted to EMA

(CercleFinance.com) - Sanofi has announced that it has submitted the dossier on fexinidazole for review by the European Medicines Agency (EMA), developed in collaboration with the Drugs for Neglected Disease initiative (DNDi), for the treatment of sleeping sickness.


Fexinidazole would be first all-oral treatment* under investigation for both first and second stages of sleeping sickness, a fatal disease, endemic in Africa, caused by the parasite Trypanosoma brucei gambiense (g-HAT).

Following a procedure that applies only to medicinal products intended exclusively for markets outside the EU, the Agency will adopt a scientific opinion after consultation with the WHO. Fexinidazole had already been granted an accelerated review by the EMA.


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