DNDi and Phinc about Fexinidazole

EMA gave a positive opinion about Fexinidazole

February 6th, we celebrated, together with our colleagues from Drugs for Neglected Diseases initiative - DNDi and partners, the positive opinion given by the European Medicines Agency about Fexinidazole, DNDi’s first “new chemical entity”: a breakthrough all-oral treatment that cures patients affected by sleeping sickness, a fatal yet neglected disease.

Definitely, we are very happy about the positive opinion given by the European Medicines Agency under Article 58 for the use of fexinidazole to treat both stage-1 and stage-2 sleeping sickness:

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of fexinidazole, the first all-oral treatment that has been shown to be efficacious for both stages of sleeping sickness. This approval is a result of clinical trials led by the non-profit research and development organization DNDi and an application submitted by Sanofi. The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.

Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment. Transmitted by the bite of a tsetse fly, it causes neuropsychiatric symptoms; including aggression, psychosis, and a debilitating disruption of sleep patterns that have given this neglected disease its name. About 65 million people in sub-Saharan Africa are at risk.

Fexinidazole, developed by DNDi in partnership with Sanofi, will support international efforts to eliminate the disease. PhinC Development is very proud to have taken part since 2009 in the “fexinidazole” story.

Dr Antoine Tarral, Head of the DNDi’ Human African Trypanosomiasis development program, said: "The PhinC Development team has accompanied us throughout this program. In particular, their expertise in pharmacokinetic modeling has enabled us to select the therapeutic dose and optimize the dose regimen. I most particularly appreciated their continuous involvement, their professionalism and their ability to work together with all the other actors involved in this program”.

Montreal International
GMP - Groupe de Métabolisme et Pharmacocinétique