fexinidazole oor Spaans
fexinidazole
en
A drug being investigated for the treatment of sleeping sickness.
Vertalings in die woordeboek Engels - Spaans
fexinidazol
Geskatte vertalings
Vertoon algoritmies gegenereerde vertalings
voorbeelde
Advanced filtering
Voorbeelde moet herlaai word.
Fexinidazole is the first new chemical entity to be successfully developed by DNDi.
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“Having an oral drug like fexinidazole as a future first-line treatment, with NECT as a second line, opens the way for a paradigm shift in how national programmes and the World Health Organization (WHO) can tackle the disease, as well as facilitating the integration of disease management in the health system,” said Dr Nathalie Strub-Wourgaft, DNDi Medical Director.
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Treatment success rates of 91.2% were measured for fexinidazole, with 97.6% for NECT, 18 months after the end of treatment.
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“Fexinidazole is an entirely new chemical entity that has been developed through an alternative non-profit R&D model.
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The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.
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Phase II Trial Launched to Test Safety and Efficacy of ‘Rediscovered’ Fexinidazole in 140 Adults with Chronic Indeterminate Chagas Disease
invita a la futura Agencia europea a establecer relaciones, por una parte, con el Consejo de Europa, las instituciones nacionales y las organizaciones no gubernamentales que trabajan por la aplicación de los derechos fundamentales y con la red de expertos independientes, e igualmente con los entes locales y regionales que, por su enfoque específico, están en situación de realizar una útil contribución a sus trabajos, y pide a la Agencia que presente un informe anual sobre la situación de los derechos fundamentales en la UniónParaCrawl Corpus ParaCrawl Corpus
With respect to the papers presented at the Workshop, he made particular mention of advances in the development of serological biomarkers of therapeutic efficacy, research into new treatments and diagnostic tests, as well as the results of studies with a new drug containing fexinidazole, which is highly effective but still requires additional investigation to improve its safety.
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Working collaboratively with public and private partners worldwide, DNDi has developed six new treatments for neglected patients, with several new drug candidates in the R&D pipeline, including two for sleeping sickness (fexinidazole, oxaborole/SCYX-7158) and one for Chagas (E1224) in clinical trials.
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Fexinidazole for Chagas Disease Trial Partners
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In 2003, MSF co-founded the Drugs for Neglected Diseases initiative (DNDi), an innovative non-for-profit drug development model to develop treatments for neglected patients, which has delivered eight treatments for malaria, pediatric HIV, leishmaniasis, Chagas disease, and sleeping sickness, including the recently launched all-oral sleeping sickness treatment fexinidazole.
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Two additional studies confirmed the efficacy of fexinidazole in haemo-lymphatic (stage-1) and early-stage-2 g-HAT patients (98.7%), and in children (97.6%), 12 months after the end of treatment.
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DNDi’s clinical development programme for Chagas disease currently pursues the evaluation of fexinidazole and new regimens of benznidazole, as a monotherapy and in combination, for the treatment of adult patients with chronic indeterminate Chagas disease in order to reduce drug exposure and improve tolerability, while maintaining or improving efficacy.
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To develop fexinidazole, DNDi spent EUR 55 million (USD 62.5 million), which includes costs related to pre-clinical development and clinical studies.
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By allowing for the participation of endemic countries (DRC and Uganda) and of the WHO in the evaluation of the fexinidazole regulatory dossier, approval under Article 58 also facilitates and could accelerate future national product registrations and patient access.
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For instance, last February it was known that for the first time the NGO DNDi had been able to develop a new drug from scratch: fexinidazole, for the treatment of the neglected disease “sleeping sickness”.
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Fexinidazole is DNDi’s first new chemical entity to successfully complete Phase II/III trials.
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In 2009, DNDi and Sanofi concluded a collaboration agreement for the development, manufacturing, and distribution of fexinidazole, with DNDi responsible for pre-clinical, clinical, and pharmaceutical development, and Sanofi for industrial development, registration, production, and distribution of the drug.
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DNDi's clinical development programme for Chagas disease currently pursues the evaluation of fexinidazole and new regimens of benznidazole, as a monotherapy and in combination, for the treatment of adult patients with chronic indeterminate Chagas disease in order to reduce drug exposure and improve tolerability, while maintaining or improving efficacy.
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“The development of fexinidazole over the past decade bears witness to the value of the alternative non-profit R&D model, and in the DNDi approach of forging strong partnerships involving WHO, disease-endemic country Ministries of Health and national control programmes, and the pharmaceutical industry,” said Dr Bernard Pécoul, DNDi Executive Director.
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Fexinidazole is effective for both stages of the disease, so will remove this need.
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In 2009, DNDi and Sanofi concluded a collaboration agreement for the development, manufacturing, and distribution of fexinidazole, with DNDi responsible for pre-clinical, clinical, and pharmaceutical development, and Sanofi responsible for industrial development, registration, production and distribution of the drug. Phase I studies began in 2010, and the Phase II/III pivotal clinical study in 2012.
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Fexinidazole is indicated as a 10-day once-a-day treatment for Trypanosoma brucei gambiense sleeping sickness (the most common form of the disease, found in West and Central Africa).
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Fexinidazole is a 5-nitroimidazole derivative that was rediscovered in 2005, through collaboration with the Swiss Tropical and Public Health Institute, during DNDi’s search for compounds with anti-parasitic activity, after being developed and then abandoned for strategic reasons by Hoechst (now Sanofi) in the 1980s.
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Fexinidazole comes as a simple pill: this is a huge leap in how we can tackle this deadly disease.”
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In the 1970s, Hoechst (now part of Sanofi) had initiated but did not pursue pre-clinical development of fexinidazole.
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34 sinne gevind in 10 ms. Hulle kom uit baie bronne en word nie nagegaan nie.