16 November 2018 - The positive opinion is the result of a 10-year partnership between the Drugs for Neglected Diseases initiative (DNDi), Sanofi and African partners.
The EMA’s 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 organisation (DNDi) and an application submitted by Sanofi. The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.