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The new drug, fexinidazole, which comes in the form of a simple pill, cures all stages of the disease in 10 days.
The first fully oral treatment for sleeping sickness has been approved for use in endemic countries starting next year (2019).
The European Medicines Agency on Friday approved the use of fexinidazole, which has been shown to be effective in treating all stages of sleeping sickness.
This approval is the result of clinical trials conducted by the Drugs for Neglected Diseases Initiative (DNDi), a non-profit research and development organization, and an application by Sanofi, a biopharmaceutical company. international focus on human health.
The new drug, fexinidazole, which comes in the form of a simple pill, cures all stages of the disease in 10 days.
The results showed that the pill could also eliminate the need for routine hospitalization following clinical trials of 749 patients in the Democratic Republic of the Congo and the Central African Republic.
"This is only the first step, and now we need to ensure that patients can access and benefit from this new drug," said Dr. Nathalie Strub-Wourgaft, Director of DNDi's Department of Health, in a statement. neglected tropical diseases.
Eflornithine, the current intravenous drug, should be administered for several days with intravenous fluids, as the drug can cause severe skin irritation that is such a burden.
But fexinidazole can be taken at home. "While current treatments are safe and effective, they require the hospitalization of a patient and constitute a huge logistical burden for the health system.
Fexinidazole comes in the form of a simple pill: it is a huge step forward in the way of fighting this deadly disease, "said Dr. Victor Kande, the # 1 pill 39, principal investigator of the trials.
Sleeping sickness or human African trypanosomiasis (HAT) is transmitted by tsetse flies. It occurs in 36 countries in sub-Saharan Africa and the most affected populations live in rural areas.
It is usually fatal without treatment. The disease causes neuropsychiatric symptoms (mental nervous disorder), including aggression.
This adds to psychosis (an altered relationship with reality) and to a debilitating disruption of sleep patterns that gives its name to this neglected disease.
Several epidemics have occurred in Africa during the last century, including one between 1896 and 1906, mainly in the Congo Basin and Uganda.
Although about 65 million people in sub-Saharan Africa are at risk, sleeping sickness is a declining disease.
Countries such as Uganda report fewer than 100 new cases a year according to the World Health Organization (WHO).
In July of this year (2018), WHO confirmed a steady decrease in the number of new cases. Only 1,447 new cases were reported to WHO in 2017, compared to 2,164 cases in 2016 and 9,870 cases in 2009.
The history of sleeping sickness is marked by an upsurge, interspersed with decades in which the disease appears to be largely under control, but WHO aims to eliminate it by 2020.
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