Sanofi et la DNDi soumettent leur traitement contre la maladie du sommeil à l’évaluation de l’Agence européenne des médicaments ​

Paris, Genève – 31 janvier 2018
Sanofi a soumis le dossier du féxinidazole dans le traitement de la maladie du sommeil à l’évaluation de l’Agence européenne des médicaments (EMA). Le féxinidazole est développé en collaboration avec la Drugs for Neglected Disease initiative (DNDi, initiative Médicaments contre les maladies négligées). Il serait le premier traitement entièrement par voie orale actuellement développé dans le traitement de la forme de trypanosomiase humaine africaine (ou maladie du sommeil) causée par le parasite Trypanosoma brucei gambiense (g-HAT). Ce médicament pourrait contribuer à l’éradication de la maladie.

Sanofi, DNDi seek European Medicines Agency review for sleeping sickness treatment

Paris, Geneva – 31 January 2018
Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). It would be the first all-oral treatment under investigation for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness. This treatment is expected to contribute to the elimination of the disease.

The challenge of conducting clinical trials in remote and conflict areas

The journey to the sleeping sickness trial site in Isangi from the DNDi office in Kinshasa begins in the domestic airport of DRC’s capital city and ends more than a day later halfway across the country in a barge crossing the Congo river. In between: hours spent navigating potholed dirt roads, collapsed bridges, checkpoints, and multiple river crossings. Once at Isangi, canoes must be used to reach many of the patients as there are no roads.

Yet for DNDi’s clinical team in DRC, Isangi is one of the easier-to-reach sites. The DRC and the Central African Republic (CAR) both pose daunting challenges that must be overcome to develop better treatments for patients suffering from sleeping sickness.

Oral fexinidazole for late-stage African Trypanosoma brucei gambiense trypanosomiasis: A pivotal multicentre, randomized, non-inferiority trial

by Kande Betu Ku Mesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Blesson S, Simon F, Delhomme S, Bernhard S, Kuziena W, Fina Lubaki JP, Lumeya Vuvu S, Nganzobo Ngima P, Mahenzi Mbembo H, Ilunga M, Kasongo Bonama A, Amici Heradi J, Lumaliza Solomo JL, Mandula G, Kaninda Badibabi L, Regongbenga Dama F, Kavunga Lukula P, Ngolo Tete D, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A.

The Lancet, November 2017

Fexinidazol, el primer tratamiento oral para la enfermedad del sueño africana, demuestra gran eficacia y seguridad en estudios Fase II/III

[Ginebra – 4 de noviembre de 2017]
Los resultados plantean un posible cambio de paradigma en el tratamiento de esta enfermedad fatal
Se comprueba la eficacia y seguridad del primer tratamiento completamente oral contra el Trypanosoma brucei gambiense, la tripanosomiasis humana africana (g-THA), más conocida como enfermedad del sueño. Los resultados son de estudios clínicos realizados por la Iniciativa Medicamentos para Enfermedades Olvidadas (DNDi, por sus siglas en inglés) y sus socios, publicado hoy en The Lancet.
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Des études de phase II/III mettent en évidence l’efficacité et la sécurité du fexinidazole, premier traitement oral contre la maladie du sommeil

[Genève – 4 novembre 2017]
Ces résultats laissent entrevoir la possibilité d’un changement de paradigme concernant le traitement de cette maladie mortelle
Les résultats d’études cliniques menées par DNDi (Drugs for Neglected Diseases initiative) et ses partenaires ont montré l’efficacité et la sécurité du premier traitement entièrement oral contre la trypanosomiase humaine africaine à Trypanosoma brucei gambiense (g-THA). Ces résultats ont été publiés aujourd’hui dans The Lancet.
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Estudos de fase II e III comprovam alta eficácia e segurança do fexinidazol, primeiro tratamento oral para a doença do sono africana

[Genebra – 4 de novembro de 2017]
Resultados abrem possibilidade de mudança de paradigma no tratamento de uma doença fatal
O primeiro tratamento exclusivamente oral para a doença do sono, a tripanossomíase africana humana, provocada pelo Trypanosoma brucei gambiense (g-HAT), teve a eficácia e segurança comprovadas por estudos clínicos liderados pela Iniciativa de Medicamentos para Doenças Negligenciadas (DNDi) e seus parceiros, publicado hoje em The Lancet.
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Phase II/III studies show high efficacy and safety of fexinidazole, the first oral treatment for sleeping sickness

[Geneva – 4 November 2017]
Results open possibility of paradigm shift in treatment of deadly disease
The first all-oral treatment for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT) has been proven to be effective and safe, according to the results of clinical trials led by the Drugs for Neglected Diseases initiative (DNDi) and its partners, published today in the Lancet.
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