Malawians are likely to benefit from first sleeping sickness oral medication which the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion.
This positive opinion, according to a statement by the Drugs for Neglected Diseases initiative (DNDi), is for the treatment in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa.
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The statement said this CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases Initiative (DNDi).
The CHMP was first adopted in 2018, a positive opinion of Fexinidazole Winthrop as the first all-oral treatment.
In Malawi, the study was led by Dr. Westain Nyirenda, who is also Rumphi District director of health and social services.
In an interview with The Atlas, Nyirenda said the first sleeping sickness oral medication is better than the current treatments which are toxic to patients.
“The study was important because Malawi is one of the endemic areas for Human African Trypanosomiasis (HAT), due to trypanosoma brucei rhodesiense. Currently, cases are still being reported from communities surrounding game reserves, mostly Vwaza Marsh and Nkhotakota game reserves.
“Over 1 million people are at risk of getting infected with the parasite from a infected tsetse bite. So the burden is there. Thats one. Second, the current treatments are toxic to patients, and need hospitalisation for treatment.
“Therefore, the new medicines that have just been given a positive scientific opinion, are both efficacious and safe. Besides, it’s an oral medicine, simple to use even in the communities. It is the first oral medication for rhodesiense HAT
“So, 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,” he said
The Ministry of Health is yet to make a decision whether to start using the oral medication or not.
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.
