“I’ve treated more than 3,000 patients since 2006,” said Dr Wilfried Mutombo, DNDi project coordinator for sleeping sickness. “If I had had fexinidazole at that time, I would have not had to hospitalise all of them and I would have had fewer relapses.”
“Most other infectious diseases are treated at a pharmacy. I hope that this will now happen for sleeping sickness.”
The drug has been approved in the DRC through an innovative regulatory mechanism to fast-track the approval of new medicines outside the European Union. A similar submission is expected from Uganda later this year.
Dr Nathalie Strub-Wourgaft, director of neglected tropical diseases at DNDi, said the swift approval since the European Medicines Agency decision in November was significant.
“We look forward to the implementation of fexinidazole as a first-line treatment and welcome this rapid approval of fexinidazole in the DRC,” she said. “[It is] a testament to the dedication of the DRC Government through the Ministry of Health to eliminate [sleeping sickness] as a public health problem by 2020.”