Sanofi and partner seek European Medicines Agency review for sleep sickness product

PARIS (Reuters): French healthcare group Sanofi, along with its business partner, has asked the European Medicines Agency (EMA) to review the fexinidazole product for the treatment of sleeping sickness, the company said on Wednesday.

Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi), a not-for-profit research organization.

It would be the first all-oral treatment under examination for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness which affects many in Africa, added Sanofi.

The 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, for the evaluation of medicinal products intended exclusively for markets outside of the European Union.

Human African Trypanosomiasis (HAT) or “sleeping sickness” is a tropical disease affecting sub-Saharan African countries.