Via mediacongo.net: Fight against sleeping sickness: DRC approves first oral treatment. Excerpt from the Google translation:
Kinshasa has granted marketing authorization for fexinidazole for the treatment of human African trypanosomiasis (HAT) or sleeping sickness.
The approval of the country opens the way for the distribution this year of fexinidazole, throughout the territory where the sleeping sickness is endemic. The Democratic Republic of Congo (DRC) is indeed one of the countries where the disease is concentrated, with nearly 85% of the reported cases.
"Having grown up in East Africa, I am very familiar with sleeping sickness. My mother still feared that this disease would affect our family," said Dr. Ameet Nathwani, Chief Medical Officer and Executive Vice President Medical Affairs Sanofi. "The approval of fexinidazole in the Democratic Republic of the Congo today gives us hope that efforts to eliminate sleeping sickness will be successful by next year," he added.
The current treatment against sleeping sickness, although effective, is very restrictive for patients and health staff because, it requires the hospitalization of patients, raising significant logistical difficulties, especially for people living in hospitals. remote areas.
Fexinidazole is approved in the DRC for the ten-day treatment of sleeping sickness caused by the parasite Tb gambiense (the most common form found in African West and Central Africa).
It is mainly the first fully oral treatment that acts both against the early phase of the disease and its second phase, when the parasite has crossed the blood-brain barrier resulting in the appearance of neuropsychiatric symptoms. Fexinidazole could therefore eliminate systematic hospitalizations of patients.
The European Medicines Agency (EMA) delivers a favorable opinion
The EMA issued a favorable scientific opinion on the marketing of fexinidazole, based on the results of clinical trials conducted by the Drugs for Neglected Diseases Initiative, a non-profit research and development organization, and on the file submitted by Sanofi.
"We look forward to deploying fexinidazole for the first-line treatment of sleeping sickness and very pleased that the DRC has approved it so quickly after the EMA's opinion. This speed of action reflects the commitment of the Congolese government, through its Ministry of Health, to eliminate HAT as a public health problem by 2020," said Dr Nathalie Strub-Wourgaft, Director of the Health and Safety Program. Neglected tropical diseases of DNDi.
"This proves the value of the Article 58 evaluation procedure, an innovative regulatory mechanism for new medicines intended exclusively for countries outside the European Union," she explained.
