Fexinidazole, the first all-oral treatment for sleeping sickness registered by Sanofi and developed in clinical trials led by the Drug for Neglected Diseases initiative (DNDi), has been added to the World Health Organization’s (WHO) Essential Medicines Lists (EML) for adults and children, for the treatment of both stages of the disease.

The EML Expert Committee recommended the addition of fexinidazole to the EML as an orally administered treatment for the first and second stages of sleeping sickness, also known as human African trypanosomiasis, due to Trypanosoma brucei gambiense.

“The WHO’s Essential Medicines List is used by countries to guide decisions on which products need to be made widely available for their populations. It will spur governments in endemic countries to include fexinidazole in their treatment guidelines,” said Dr Nathalie Strub-Wourgaft, DNDi’s Director of Neglected Tropical Diseases. “Inclusion of fexinidazole is also a further sign of WHO and Sanofi’s commitment to ensuring swift deployment of this paradigm-changing treatment.”

Sleeping sickness is a neglected tropical disease, transmitted by the bite of a tsetse fly. Without prompt diagnosis and treatment, sleeping sickness is usually fatal, as the parasites invade the central nervous system. 65 million people, who live mainly in rural parts of East, West and Central Africa, are at risk of contracting sleeping sickness.

On 16 November 2018, the European Medicines Agency (EMA) adopted a positive scientific opinion of fexinidazole – a result of clinical trials led by DNDi and an application submitted by Sanofi.

Photo credit: Xavier Vahed-DNDi