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.
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.
“The acceptance by the EMA of the fexinidazole regulatory dossier is a critical step in the registration process. Results of the Phase II/III clinical trials conducted with our partners in Democratic Republic of Congo and the Central African Republic, which were published in The Lancet* last November, showed the product to be effective and well tolerated,” said Dr. Nathalie Strub-Wourgaft, DNDi Medical Director.
Dr. Ameet Nathwani, Chief Medical Officer, Sanofi, said: “This milestone is the result of an innovative collaboration between Sanofi and DNDi to address the burden of sleeping sickness. Fexinidazole is being developed with the goal of addressing all stages of sleeping sickness and simplifying treatment by avoiding systematic hospitalization. It could represent a therapeutic breakthrough foremost for the patients and potentially support elimination efforts as per the WHO 2020 Roadmap.”