TB Alliance Statement on EMA Approval of Fexinidazole

Regulatory approval of all-oral sleeping sickness medication is a global health breakthrough

November 19, 2018

November 19, 2018 - NEW YORK - TB Alliance congratulates DNDi and its partners on receiving a positive scientific opinion of fexinidazole from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use. Fexinidazole is the first all-oral treatment that has shown efficacy against Trypanosoma brucei gambiense, the most common form of sleeping sickness. This often-fatal neglected disease is found in 24 countries in west and central Africa, with the majority of these cases occurring in the Democratic Republic of Congo.

The application for this new drug, which was submitted by Sanofi, is the result of scientific research and evidence generation through clinical trials. Donor countries and foundations made significant, long-term investments to advance this work. With EMA approval paving the way for introduction of this treatment, these commitments will soon result in lives saved from this deadly illness.
This innovation is truly a breakthrough and a great success story for global health. It is a testament to the strength of the non-profit product development model used by DNDi to advance scientific research and product development for diseases of poverty and neglect.
As with any impactful new treatment, it is our expectation that it will be swiftly adopted by countries and reach the people who need it as soon as possible. With further investments in global health breakthroughs like fexinidazole, we will continue to see great progress against diseases of poverty.


Photo credit: Xavier Vahed-DNDi