French drugmaker Sanofi’s fexinidazole-basesd all-oral treatment for sleeping sickness (Trypanosoma brucei gambiense human African trypanosomiasis, HAT) has received marketing authorization from the Democratic Republic of Congo (DRC), the most important market for the drug.

The approval paves the way for fexinidazole’s distribution in Congo and other endemic countries this year, with another submission planned in Uganda. The EU is also in the process of approving the treatment.

About 65 million people in sub-Saharan Africa are said to be at risk from the disease transmitted by the bite of a tsetse fly and usually fatal without treatment. The medication helps fight neuropsychiatric symptoms including aggression, psychosis and a debilitating disruption of sleep patterns.

Current treatment options, while effective, are burdensome for patients and health workers, Sanofi said, requiring logistical challenges of hospitalization that are especially challenging for people living in remote areas.

Fexinidazole is approved in the DRC as a 10-day once-a-day treatment for T.b. gambiense sleeping sickness, the most common form of the disease in West and Central Africa. It is claimed to be the first all-oral treatment both the early and late stages of the disease.

In November 2018, The European Medicines Agency (EMA) adopted a positive scientific opinion of fexinidazole, following clinical trials led by the non-profit R&D initiative Drugs for Neglected Diseases (DNDi) and an application submitted by Sanofi.

By allowing for the participation of endemic countries (DRC and Uganda) and of the World Health Organization (WHO) in the evaluation of the fexinidazole regulatory dossier, Sanofi said the pending EMA approval under Article 58 could accelerate future national product registrations and patient access.