FDA Approves Sleeping Sickness Therapy

The federal agency gives nod for fexinidazole as the first all-oral treatment for the parasitic illness.

The US Food and Drug Administration announced it has approved the therapy, fexinidazole, for the treatment of African Trypanosomiasis, which is commonly known as Sleeping Sickness.

With the approval, fexinidazole becomes the first all-oral treatment to treat it. Previously, the treatment required an infusion or injection, which involved hospitalization, making it difficult as the illness mostly affects people in remote areas of sub-Saharan Africa. The existing treatment has been efficacious, but fexinidazole makes treatment more convenient as it is indicated as a 10-day once-a-day treatment.

Fexinidazole was developed as part of an 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, Central African Republic, and Sanofi.

“Having a simple, all-oral treatment for sleeping sickness is a dream come true for frontline clinicians,” Bernard Pécoul,MD, DNDi executive director, said.“We are proud of this latest milestone in our long-term partnership with Sanofi, developed in close collaboration with researchers in countries hard-hit by sleeping sickness.”

The parasitic illness comes from the species Trypanosoma brucei, which is transmitted by the tsetse fly found only in rural Africa. According to the Centers for Disease Control and Prevention (CDC), “occasionally an infected pregnant woman may pass T. brucei gambiense infection to her baby. Other routes of transmission are possible though rare and poorly documented (sexual, blood transfusion and organ transplantation).”

If left untreated, it is fatal. The CDC reported fewer than 2000 cases in 2017-2018.