Die Europäische Arzneimittel-Agentur empfiehlt Fexinidazol, die erste rein orale Behandlung gegen die Schlafkrankheit

Paris/Genf, 16. November 2018

  • Die positive Stellungnahme der EMA ist das Ergebnis einer zehnjährigen Partnerschaft zwischen der Drugs for Neglected Diseases initiative (DNDi), Sanofi und afrikanischen Partnern.
  • Fexinidazol wird die internationalen Bemühungen zur Eliminierung der Schlafkrankheit unterstützen, einer tödlich vernachlässigten tropischen Krankheit, die in Afrika endemisch ist.

Der Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittel-Agentur (EMA) hat ein positives wissenschaftliches Gutachten zu Fexinidazol erstellt, der ersten rein oralen Behandlung, die sich in beiden Stadien der Schlafkrankheit als wirksam erwiesen hat. Diese Genehmigung ist das Ergebnis klinischer Studien, die unter der Leitung der gemeinnützigen Forschungs- und Entwicklungsorganisation DNDi durchgeführt wurden, und eines von Sanofi gestellten Antrags. Die Entscheidung ebnet den Weg für die Bereitstellung von Fexinidazol in endemischen Ländern ab 2019.

L’Agence européenne des médicaments recommande l’approbation du fexinidazole, le premier traitement entièrement par voie orale de la maladie du sommeil

Paris/Genève, 16 Novembre 2018

  • L’avis favorable de l’EMA est l’aboutissement d’une collaboration de 10 ans entre Drugs for Neglected Diseases initiative (DNDi), Sanofi et plusieurs partenaires africains
  • Le fexinidazole sera un atout pour les efforts déployés à l’échelle internationale en vue d’éliminer la maladie du sommeil, une maladie tropicale négligée, mortelle et endémique en Afrique

Le Comité des médicaments à usage humain (Committee for Medicinal Products for Human Use ; CHMP) de l’Agence européenne des médicaments (EMA) a rendu un avis favorable au sujet du fexinidazole, le premier traitement entièrement par voie orale ayant fourni la preuve de son efficacité contre les deux phases de la maladie du sommeil. Cet avis repose sur les essais cliniques menés par DNDi, une organisation de recherche et développement à but non lucratif, dont les résultats ont été soumis dans le dossier présenté par Sanofi. Cette décision ouvre la voie à la distribution de ce produit en 2019, dans les pays où la maladie du sommeil est endémique.

European Medicines Agency recommends fexinidazole, the first all-oral treatment for sleeping sickness

Paris/Geneva – 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
  • Fexinidazole will support international efforts to eliminate sleeping sickness, a fatal neglected tropical disease endemic to Africa

The European Medicines Agency’s Committee for Medicinal Products for Human Use (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 organization DNDi and an application submitted by Sanofi. The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.

A Agência Europeia de Medicamentos recomenda o uso do fexinidazol, o primeiro tratamento exclusivamente oral para a doença do sono

Paris/Genebra, 16 de novembro de 2018

  • A recomendação positiva é resultado de uma parceria de 10 anos entre a Iniciativa Medicamentos para Doenças Negligenciadas (DNDi), a Sanofi e parceiros africanos
  • O fexinidazol ajudará no esforço internacional para a eliminação da doença do sono, uma doença tropical negligenciada que é endêmica na África e pode ser fatal

O Comitê dos Medicamentos para Uso Humano (CMUH) da Agência Europeia de Medicamentos emitiu uma opinião científica positiva sobre o fexinidazol, o primeiro tratamento exclusivamente oral que se mostrou eficaz em ambos os estágios da doença do sono. Esta recomendação é resultado de ensaios clínicos liderados pela DNDi, organização sem fins lucrativos de pesquisa e desenvolvimento, e de um pedido de registro submetido pela Sanofi. A decisão abre o caminho para a distribuição do fexinidazol nos países afetados a partir de 2019.

La Agencia Europea de Medicamentos recomienda fexinidazol, el primer tratamiento exclusivamente oral para la enfermedad del sueño

Paris/Ginebra, 16 de noviembre de 2018

  • La opinión positiva es el resultado de una alianza de 10 años entre la Iniciativa Medicamentos para Enfermedades Olvidadas (DNDi), Sanofi y asociados africanos.
  • El fexinidazol respaldará los esfuerzos internacionales para erradicar la enfermedad del sueño, una enfermedad tropical desatendida y fatal que es endémica en África.

El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos adoptó una opinión positiva acerca del fexinidazol, el primer tratamiento exclusivamente oral que ha demostrado ser eficaz en ambas fases de la enfermedad del sueño. Esta aprobación es el resultado de ensayos clínicos conducidos por la DNDi, una organización de investigación y desarrollo sin fines de lucro, y de la solicitud presentada por Sanofi. La decisión allana camino para la distribución del fexinidazol en los países endémicos en el 2019.

ASTMH 2018

67th Annual Meeting

28 October – 1 November 2018
New Orleans, USA

  • Nathalie Strub-Wourgaft, NTD Director – presentation on fexinidazole in a symposium on sleeping sickness elimination
  • Colin Forsyth, Chagas Epidemiologist, Sergio Sosa Estani, Head of Chagas Clinical Programme, Eric Chatelain, Head of Drug Discovery Programme – symposium on screening and diagnosis of Chagas disease
  • Poster and oral presentations on sleeping sickness, visceral leishmaniasis, Chagas, onchocerciasis, and mycetoma

New hope for PKDL patients in Africa as clinical trial aims to make treatment safer and easier

Nairobi/Khartoum – 12 September 2018

Trial to take place in Sudan, which has the world’s highest rates of this highly stigmatizing disease
A clinical trial to find a better treatment for severe or chronic cases of post kala-azar dermal leishmaniasis (PKDL) in Africa has begun in Dooka, Sudan. The objective of this clinical trial, which is being conducted by the DNDand the Institute for Endemic Diseases at the University of Khartoum, is to shorten the length of hospitalization for PKDL, and deliver a treatment that is safer to use and easier to administer.

DNDi contribution to the World Health Organization roadmap on access to medicines and vaccines 2019-2023

10 September 2018
Geneva, Switzerland

As a contribution to the World Health Organization roadmap on access to medicines and vaccines, Dr Bernard Pécoul noted the importance of including concrete deliverables in the short-, medium-, and long-term, including prioritization of R&D, open and collaborative approaches to innovation, regulatory infrastructure, and solving gaps in diagnostics and specific needs of children.