Fexinidazole is a 10-day oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), a fatal disease more commonly known as sleeping sickness.
The Paris, France-based drugmaker said it is hoped that the treatment will contribute to the elimination of the disease.
The European Medicines Agency has accepted the application under a special procedure called “Article 58”, which allows it to give a scientific opinion, in co-operation with the World Health Organisation (WHO), for medicinal products intended exclusively for markets outside of the EU.
“The acceptance by the EMA of the fexinidazole regulatory dossier is a critical step in the registration process,” said Dr Nathalie Strub-Wourgaft, DNDi Medical Director.
“Results of the Phase II/III clinical trials conducted with our partners in Democratic Republic of Congo and the Central African Republic, which were published in The Lancet last November, showed the product to be effective and well tolerated.”