US FDA approves fexinidazole, first all-oral treatment for sleeping sickness

The US Food and Drug Administration has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients six years of age and older and weighing at least 20 kg.

Fexinidazole was developed as part of an innovative partnership between the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), which conducted the pivotal clinical trials for this treatment, in partnership with the National Sleeping Sickness Programs of the Democratic Republic of Congo (DRC) and Central African Republic (CAR), and French pharma major Sanofi (Euronext: SAN).

Through Sanofi’s collaboration the number of sleeping sickness cases reported to the World Health Organization (WHO) has been reduced by ~97% between 2001 and 2020. DNDi, Sanofi and partners are deeply committed to ensuring access to fexinidazole in all sleeping sickness-endemic countries.