A breakthrough in the fight against sleeping sickness: Fexinidazole, the first oral treatment approved by the EMA

The pharmaceutical group Sanofi announced this Friday, December 15, 2023 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a favorable opinion on fexinidazole Winthrop as the first oral treatment for the acute form of sleeping sickness.

This opinion from the Committee for Medicinal Products for Human Use (CHMP) follows clinical studies carried out in Malawi and Uganda by the non-profit medical research organization, Drugs for Neglected Diseases Initiative (DNDi).

The data ofthe clinical studyDNDi phase 2/3 studies presented recently at the European Congress of Tropical Medicine and International Health (ECTMIH) showed that Fexinidazole was very effective in treating sleeping sickness caused byT.b. rhodesiense, and that it constituted a safe alternative to existing drugs. Follow-up assessments carried out regularly for 12 months after treatment indicated that only one patient (2.94%), who had reached the blood-brain stage of the disease, had relapsed and had to be treated with the arsenic derivative which constitutes the standard treatment for the most severe stage of sleeping sickness.

“This favorable opinion concerns the treatment, in adults and children aged six years or over weighing at least 20 kg, of the first stage (hemo-lymphatic) as well as the second stage (meningo-encephalitic) of sleeping sickness caused by Trypanosoma brucei rhodesiense, an acute and fatal form of this disease endemic in East and Southern Africa”, according to the European Medicines Agency (EMA).

Transmitted by the bite of an infected tsetse fly, sleeping sickness or human African trypanosomiasis (HAT) is usually fatal if left untreated. These flies, present in 36 African countries, their bite causes neuropsychiatric symptoms, such as aggression, psychosis and disabling sleep disorders, and leads to death.

“The CHMP's positive opinion marks another milestone in Sanofi's commitment to providing innovative treatments for vulnerable patient communities affected by sleeping sickness, a deadly neglected tropical disease. Our collaboration with WHO and DNDi has allowed us to make enormous progress in improving treatments and simplifying their administration. This partnership and our donation of Fexinidazole through the Foundation is a reflection of our mission to provide innovative treatments to patients, no matter where they live.",declared Dietmar Berger, MD, PhD, Head of Development and Medical Director, Sanofi on the said institution's website.

The CHMP had already issued a favorable opinion in 2018 for fexinidazole as the first oral treatment for the most common form of sleeping sickness. DNDi and Sanofi entered into a collaboration agreement on fexinidazole in 2009. DNDi is responsible for preclinical, clinical and pharmaceutical development activities and Sanofi, industrial development, registration, production and distribution of the drug.

According to, Sanofi, DNDi and the HAT-r-ACC consortium, Fexinidazole is already registered in the Democratic Republic of Congo and Uganda for the treatment of sleeping sickness inT.b. gambiense, and its use is recommended in ten other African countries including Angola, Burkina Faso, Central African Republic, Chad, Congo, Ivory Coast, Equatorial Guinea, Gabon, Guinea and South Sudan.

Read the article in English on the DNDi website.

Mamadou Kindy BAH