The European green light for fexinidazole from Sanofi, the first fully oral treatment for sleeping sickness, validates a new research model, combining public and private, in neglected tropical diseases. The French will provide and distribute the drug free of charge in Africa, where 65 million people are at risk.
Bet won. Ten years after launching an unprecedented partnership with the NGO Drugs for Neglected Diseases initiative (DNDi), Sanofi is taking a decisive step in the treatment of sleeping sickness, a deadly infectious parasitic disease endemic in Africa. On November 16, the European Medicines Agency (EMA) issued a favorable opinion on fexinidazole, its molecule having shown its effectiveness against the two key stages of this disease. What pave the way for its distribution by the WHO from spring 2019 in the most affected countries.
Transmitted by the bite of an infected tsetse fly, sleeping sickness (or human African trypanosomiasis, HAT) is fatal without treatment. It first manifests itself in the patient with symptoms similar to malaria (headache, fever, etc.) – thus complicating its diagnosis – followed by a second stage where the patient suffers from serious sleep disorders, paralysis and mental deterioration, similar to insanity, leading to a coma. Some 65 million people are now at risk in sub-Saharan Africa, particularly in the Democratic Republic of Congo (DRC) and the Central African Republic where the final phases of clinical trials of fexinidazole have been carried out.
Real medical breakthrough
For Sanofi, which is committed to producing, supplying and distributing fexinidazole free of charge to the WHO, this image victory – the right to health for all everywhere in the world, the laboratory’s leitmotif – is of first of all, a real medical breakthrough. The Frenchman concluded in 2001 with the WHO a partnership in neglected tropical diseases – also the original specialty of its director general since 2015, Olivier Brandicourt. Developed in the 1980s by the German laboratory Hoechst (which became Sanofi after the string of mergers in the sector), fexinidazole was then abandoned, without the researchers really targeting it for sleeping sickness.