Malawi helps in sleeping sickness drug breakthrough
European Medicines Agency (EMA) has approved fexinidazole winthrop as the first oral treatment for acute sleeping sickness following successful clinical trials conducted in Malawi and Uganda.
Researchers conducted the trials in the two African countries with funding from the European and Developing Countries Clinical Trials Partnership Association programme supported by the European Union, according to a press release issued on Friday.
The statement said that the medicine showed positive results, especially after treatment of adults and children six years of age or older and weighing at least 20 kilogramme (kg).
“The treatment is for both first-stage and second-stage sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa,” it reads in part.
Sleeping sickness, or human African trypanosomiasis, 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.
The trials’ principal investigator Dr Westain Nyirenda, who is a physician at Rumphi District Hospital, in an interview said the positive results pave the way for distribution of the drug.
“What it means is that they agree with us that the clinical trials were conducted according to international standards. And, therefore, the results are credible. With that opinion, it means that we can proceed for its registration and distribution for the drug for use,” he said.
Nyirenda said in Malawi, a population of one million who live near game reserves in Nkhotakota and Rumphi, among others, are at risk of contracting the disease.
He said: “These would be among the key beneficiaries of the medication as sleeping sickness is a terrifying disease that progresses more rapidly and kills 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.”
Sanofi head of development and chief medical officer Dietmar Berger said the positive result is another step forward in their commitment to help deliver innovative treatments to vulnerable patient communities impacted by sleeping sickness.
Meanwhile World Health Organisation director of Neglected Tropical Diseases, Ibrahima Socé Fall hailed the researchers for the breakthrough.
