The EMA has offered its endorsement for fexinidazole, which is billed as the first all-oral drug for sleeping sickness.
The Drugs for Neglected Diseases initiative handled the clinical trial work for the drug, with its partners at Sanofi handling the application part. A group of 7 European countries packed the $62.5 million development campaign for the drug, with some added support coming from the Bill & Melinda Gates Foundation and Médecins Sans Frontières.
The drug was put through its clinical paces using a non-profit model. Sanofi will now manage the production and distribution end of the project.
“Fexinidazole is an entirely new chemical entity that has been developed through an alternative non-profit R&D model. It is the first new chemical entity to be developed by DNDi,” said Bernard Pécoul, DNDi’s executive director.
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