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.

Malaysia takes the lead on a public health approach to hepatitis C with new initiative to enhance diagnosis & treatment

New agreement between Clinical Research Malaysia & FIND on R&D for hepatitis C diagnostic tests continues an existing Malaysian partnership with DNDi for hepatitis C treatment

The Foundation for Innovative New Diagnostics (FIND) and Clinical Research Malaysia (CRM), both DNDi partners, recently signed a memorandum of understanding (MoU) to collaborate in the research and development of an innovative hepatitis C diagnostic testing strategy.

FIND and DNDi team up to support Malaysian MOH efforts to simplify and decentralize hepatitis C screening & treatment

Amsterdam/Geneva – 23 July 2018
Initiative in Malaysia to enhance country’s public health approach to hepatitis C
FIND and the DNDi will partner to generate evidence that will support policy change and scale up of hepatitis C diagnosis and treatment. This work, announced at the AIDS 2018 conference in Amsterdam and ahead of World Hepatitis Day 2018, is being conducted in collaboration with the Ministry of Health in Malaysia with a view to overcoming barriers to diagnosis and treatment.

11th DNDi Partners’ Meeting: From innovation to access in Africa – the way forward

4 October 2018
Kampala, Uganda

  • DNDi’s biannual partners’ meeting will bring together some 250-300 health leaders, policy-makers, researchers, civil society groups, product developers, and donors.
  • Meeting sessions will highlight the significant changes made and those still needed in the landscape of research and development, capacity building and strengthening, and access to medicines for neglected diseases and patients on the African continent.

Ninth EDCTP Forum

17-21 September 2018 
Lisbon, Portugal
DNDi – symposia on synergies between diagnostics and treatment studies for HAT and on data-sharing

DNDi agreement with Colombia Ministry of Health and Social Welfare to guarantee access to comprehensive care for Chagas patients

Bogotá, Colombia – 14 April 2018
Objective is to improve access to diagnosis and treatment of people affected by this disease
An agreement to facilitate and strengthen access to diagnosis and treatment of patients with Chagas and other diseases of public health interest has been signed by the Colombian Ministry of Health and Social Protection and the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi).

New affordable hepatitis C combination treatment shows 97% cure rate

Paris – 12 April 2018
Results support a public health approach to hepatitis C
An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases, according to interim results from the Phase II/III STORM-C-1 trial presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.

Takeda Pharmaceutical and DNDi collaborate to progress a potential new drug for visceral leishmaniasis through the R&D pipeline

Osaka, Japan and Geneva, Switzerland – 5 April 2018
Efforts funded by the Global Health Innovative Technology Fund for pre-clinical and phase I clinical studies
Takeda Pharmaceutical Co., Ltd. and DNDtoday announced that they have signed an agreement to collaborate in conducting preclinical and phase I clinical studies on drug candidate compounds that had been discovered among the aminopyrazole compound class, aimed at developing an innovative drug for the treatment of visceral leishmaniasis (VL).
[Japanese]

MSF Scientific Days 2018

24-25 May 2018
London, UK
Olawale Salami, Paediatric HIV Clinical Project Manager DNDi Africa – poster about the LIVING study on treatment for paediatric HIV

DNDi, GlaxoSmithKline, and University of Dundee to identify drug candidates to treat leishmaniasis and Chagas disease

Geneva / Brentford / Dundee – 27 March 2018
The not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) will collaborate with GlaxoSmithKline (GSK), and the University of Dundee Drug Discovery Unit (DDU), in a bid to discover new pre-clinical drug candidates targeting two parasitic neglected tropical diseases (NTDs), leishmaniasis and Chagas disease.