Sanofi and DNDi apply for EU approval of sleeping sickness therapy

Sanofi has announced that it will be seeking EU approval of fexinidazole, a promising new treatment for sleeping sickness.

Developed in collaboration with the Drugs for Neglected Disease Initiative (DNDi), the therapy has been developed as the first all-oral treatment for Trypanosoma brucei gambiense human African trypanosomiasis, and is intended to contribute to the elimination of the disease.

The European Medicines Agency has accepted the application under a special procedure called Article 58, which allows the agency to give a scientific opinion for the evaluation of a medicinal product intended exclusively for markets outside of the EU.

Dr Ameet Nathwani, chief medical officer at Sanofi, said: "Fexinidazole is being developed with the goal of addressing all stages of sleeping sickness and simplifying treatment by avoiding systematic hospitalisation."

Around 60 million people in rural parts of east, west and central Africa are at risk of contracting sleeping sickness, which is caused by parasites invading the central nervous system and is usually fatal without prompt diagnosis and treatment.

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