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EMA review for sleeping sickness treatment sought by Sanofi and DNDi.

M2 EQUITYBITES-January 31, 2018-EMA review for sleeping sickness treatment sought by Sanofi and DNDi


Sanofi SA (EPA: SAN) is seeking a review of fexinidazole for the treatment of sleeping sickness from the European Medicines Agency (EMA), the company disclosed on Wednesday.

Sanofi is developing fexinidazole in collaboration with the Drugs for Neglected Diseases initiative (DNDi).

Human African trypanosomiasis (HAT), or sleeping sickness, is a tropical disease that affects sub-Saharan African countries. It is thought that 60 million people living in mainly rural parts of East, West and Central Africa are at risk of contracting the illness. Without quick diagnosis and treatment, sleeping sickness is usually fatal, as the parasites invade the central nervous system.

If the EMA decides to review the treatment, it would be the first all-oral treatment being investigated for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT). It is hoped that the drug will help to eliminate the disease, which is part of the World Health Organisation's target of eliminating neglected tropical diseases.

The EMA previously granted fexinidazole accelerated assessment and has now accepted the application under a special procedure called 'Article 58', allowing the regulatory body to give a scientific opinion in co-operation with the WHO to evaluate medicinal products that are intended exclusively for markets outside the EU.

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Publication:M2 EquityBites (EQB)
Date:Jan 31, 2018
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