Malawi first to roll out oral Fexinidazole for fatal sleeping sickness
This marks a major shift in the treatment of this fast-moving and often fatal disease, which is spread by the bite of the tsetse fly and has long affected parts of East and Southern Africa, including Malawi, one of the hardest-hit countries.
MALAWI—For the first time, patients in Malawi facing the deadly threat of Rhodesiense sleeping sickness can take a pill instead of enduring toxic intravenous (IV) drugs.
This marks a major shift in the treatment of this fast-moving and often fatal disease, which is spread by the bite of the tsetse fly and has long affected parts of East and Southern Africa, including Malawi, one of the hardest-hit countries.
Rhodesiense sleeping sickness, officially known as human African trypanosomiasis (HAT), is caused by the parasite Trypanosoma brucei rhodesiense.
The disease progresses rapidly, with early symptoms such as fever, headaches, and joint pain quickly escalating to brain damage, personality changes, coma, and, if untreated, death-sometimes within weeks.
There are two main types of sleeping sickness: a slower form found in West and Central Africa, and the faster, more deadly rhodesiense strain found in East and Southern Africa.
Between 2019 and 2021, Malawi experienced a significant outbreak of the rhodesiense form, revealing major gaps in access to effective treatment, especially in rural areas.
Even tourists on safari were infected, highlighting the broad risk posed by the disease.
Traditionally, the only available treatment was hospitalization and IV injections of melarsoprol, an arsenic-based drug with severe side effects.
Alarmingly, 5-10% of patients died from the treatment itself, rather than the disease.
Now, a breakthrough has arrived with the approval and rollout of Fexinidazole Winthrop, the world’s first all-oral treatment for rhodesiense sleeping sickness.
This pill treats both early and advanced stages of the illness and can be taken at home, eliminating the need for painful injections and lengthy hospital stays.
The treatment consists of a 10-day course and is available free of charge through the World Health Organization (WHO).
Fexinidazole Winthrop was approved in Malawi in December 2024 and is already saving lives across the region.
The development and introduction of this drug is the result of a partnership between public and private organizations, including the Drugs for Neglected Diseases initiative (DNDi), Sanofi, national sleeping sickness programs, and academic institutions across Africa and Europe.
The medication is donated by Sanofi and distributed by WHO, ensuring that cost is not a barrier for patients.
Dr. Westain Nyirenda, who led the clinical trials in Malawi, called this a historic achievement for the country’s health system.
He emphasized that moving treatment from hospitals to the community gives people a real chance to survive.
Dr. Junior Matangila, DNDi’s program head, echoed this optimism, stating that oral drugs like Fexinidazole Winthrop provide a powerful new tool to turn the tide against the disease.
However, experts warn that climate change is expanding the tsetse fly’s habitat, increasing the risk of future outbreaks, especially in forests and game parks where human-animal contact is rising.
Without ongoing monitoring and easy access to treatment, more outbreaks are likely. According to WHO, over 70 million people in 36 sub-Saharan African countries remain at risk of sleeping sickness.
While significant progress has been made in reducing cases of the slower gambiense form of the disease, leading to its elimination as a public health problem in several countries, the rhodesiense strain remains much harder to control.
This is largely because it can infect animals such as cattle and wild game, creating a persistent reservoir for the parasite.
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