Democratic Republic of Congo approves fexinidazole to treat sleeping sickness. Sanofi

Marketing authorization of fexinidazole for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT), more commonly known as sleeping sickness, has been granted in the Democratic Republic of Congo (DRC). This approval paves the way for the distribution of fexinidazole in endemic countries this year, with another submission planned in Uganda.

On 16 November 2018, The European Medicines Agency (EMA) adopted a positive scientific opinion of fexinidazole - a result of clinical trials led by the non-profit research and development organization the Drugs for Neglected Diseases initiative (DNDi) and an application submitted by Sanofi.

Comment: The majority of sleeping sickness patients live in the Democratic Republic of Congo, where 85% of Trypanosoma brucei gambiense sleeping sickness cases were reported in 2017, followed by the Central African Republic, Guinea and Chad. The latest data released by the WHO in July 2018 confirm a sustained decrease in the number of new cases. Only 1,447 new cases were reported to the WHO in 2017 compared to 2,164 cases in 2016 and 9,870 cases in 2009. But the history of sleeping sickness is marked by resurgence, interspersed by decades where the disease has seemed largely under control. In its roadmap on neglected tropical diseases published in 2012 and supported the same year by the London Declaration, the WHO included sleeping sickness, and targets its elimination as a public health problem by 2020.