The European Medicines Agency (EMA) has given a positive opinion of a drug, Fexinidazole as the first oral treatment of an acute form of sleeping sickness called rhodesiense found in East and Southern Africa.
According to a statement released on Friday, EMA’s Committee for Medicinal Products for Human Use (CHMP) said the greenlight is for treatment in adults and children six years of age or older and weighing at least 20 kg, of both first-stage and second-stage rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease.
Trials for this drug are underway in Uganda and Malawi, led by a non-profit medical research organization Drugs for Neglected Diseases Initiative (DNDi).
Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment. Both forms of sleeping sickness are transmitted by the bite of infected tsetse flies, which are found in 36 African countries. It causes neuropsychiatric symptoms, including aggressiveness, psychosis, a debilitating disruption of sleep patterns that have given this neglected disease its name, and ultimately, death.
Commenting about this development, Dietmar Berger, the Head of Development and Chief Medical Officer at Sanofi, the manufacturer of the drug under study said the positive opinion is an indicator of tremendous progress in improving treatment outcomes and simplifying treatment delivery to patients no matter where they live in the world.
For the T.b. rhodesiense variant responsible for acute disease, Fexinidazole Winthrop is taken as a 10-day, once-daily oral treatment.
Data from DNDi’s clinical trial were recently presented at the European Congress of Tropical Medicine and International Health and showed that Fexinidazole Winthrop was highly effective in treating the T.b. rhodesiense form of sleeping sickness and is a safe alternative to the existing drugs.
In periodic follow-up evaluations that continued for 12 months after treatment, only one patient (2.94%) with the advanced form of the disease had relapsed and required treatment with the arsenic derivative which is the standard of care for patients with the most severe stage of the disease.
‘T.b. rhodesiense sleeping sickness is a terrifying disease that progresses more rapidly than T.b. gambiense, killing quickly if untreated. Until now, due to the lack of innovation for this strain of sleeping sickness, old and toxic treatment options have to be administered in a hospital under strict surveillance. Having a simple and safer oral pill to treat this frightening disease will allow doctors to rapidly save lives. It will also help patients to trust the new treatment,’ said Dr Westain Nyirenda, Principal Investigator and physician at Rumphi Hospital in Malawi.
While humans are the main host of T.b. gambiense, T.b. rhodesiense is a zoonotic disease, meaning that the infection can spread from animals to humans. Cattle and wild animals such as bushbucks and zebras are the most common reservoirs for this disease.
Movements of these animals – potentially sparked by droughts or climate changes could put new populations at risk of T.b. rhodesiense sleeping sickness. In some cases, tourists visiting game reserves have been infected with T.b. rhodesiense.
‘We are already seeing how an all-oral treatment for T.b. gambiense sleeping sickness has simplified the treatment of this variant in countries like the Democratic Republic of Congo. Although there are comparatively few cases of T.b. rhodesiense, last year Ethiopia recorded its first cases since the 1970s. The drought at the time of the infections brought humans and cattle in closer proximity to the tsetse flies’ habitat. Environmental changes could be one of the reasons behind this resurgence,’ said Dr Olaf Valverde Mordt, Clinical Project Leader for sleeping sickness at DNDi.
According to the World Health Organisation, the impact of climate change extends to the shifting geographical spread of vector-borne diseases such as sleeping sickness, heightening the likelihood of spillover events where diseases transfer from animals to humans.
Dr Ibrahima Socé Fall, Director of Neglected Tropical Diseases at the organization says these shifts disproportionately affect the most vulnerable communities, underscoring the urgency of sustained investment in programs addressing NTDs.
Fexinidazole Winthrop has already been registered in the Democratic Republic of the Congo and Uganda as a treatment for T.b. gambiense and is recommended for use in a further 10 African countries including Angola, Burkina Faso, Central African Republic, Chad, Congo, Côte d’Ivoire, Equatorial Guinea, Gabon, Guinea, and South Sudan.
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