EMA review of sleeping sickness treatment requested by Sanofi

Sanofi has requested a review by the European Medicines Agency (EMA) of its treatment for sleeping sickness, fexinidazole, which it is developing in collaboration with the Drugs for Neglected Disease initiative (DNDi).

This treatment would be the first all-oral treatment under investigation for sleeping sickness — Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT). It is hoped that it will contribute to the eradication of the disease.

The application from Sanofi has been accepted by the EMA under ‘Article 58’ — a special procedure that allows the agency 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,” said Dr Nathalie Strub-Wourgaft, DNDi medical director. “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.”

Once the dossier has been evaluated, the EMA will publish its scientific opinion on the benefit-risk profile of the treatment. This will then be used to facilitate the registration of the treatment in HAT-endemic countries.

“This milestone is the result of an innovative collaboration between Sanofi and DNDi to address the burden of sleeping sickness,” said Dr Ameet Nathwani, chief medical officer, Sanofi. “Fexinidazole is being developed with the goal of addressing all stages of sleeping sickness and simplifying treatment by avoiding systematic hospitalisation. It could represent a therapeutic breakthrough foremost for the patients and potentially support elimination efforts as per the WHO 2020 Roadmap.”