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.
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 DNDi and 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.
Recife, Brazil – September 2018
DNDi and the Oswaldo Cruz Foundation, along with diverse national stakeholders, are partnering to improve access to diagnosis and treatment for Chagas disease in Brazil. The collaborative project was launched during the 54th Congress of the Brazilian Society of Tropical Medicine held in the city of Recife in northeast Brazil.
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.
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).
Buenos Aires, Argentina – 13 April 2018
Argentina has approved the paediatric indication of a drug used for treatment of Chagas disease, benznidazole, which will now be available in 12.5 mg pills, the dose required to treat children under the age of 2. The indication was approved by the Argentinian National Administration for Drugs, Food, and Medical Technologies (ANMAT).
Addis Ababa – 13 April 2018
Study launched as part of new Afri-KA-DIA Consortium will also assess diagnostic tools
A new study to find a safer, efficacious and more patient-friendly treatment and improved diagnostic tools for people living with visceral leishmaniasis (VL) has begun in eastern Africa, within the new Afri-KA-DIA consortium with funding from The European & Developing Countries Clinical Trials Partnership (EDCTP). The large-scale Phase III clinical trial seeks to assess the efficacy and safety of a combination of miltefosine and paromomycin in treating VL in eastern Africa.
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.
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 DNDi today 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).
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.
Buenos Aires, Geneva – 5 March 2018
A new collaboration between pharmaceutical companies and non-profit organizations will manufacture and supply a new, more affordable, hepatitis C treatment regimen in Latin America. An estimated 3.5 million people live with this viral disease in Latin America including around 325,000 in Argentina, with high treatment prices one of the many barriers to access for life-saving care.
Geneva, Rotterdam, Sydney – 6 February 2018
The MycetOS (Mycetoma Open Source) project was launched today by the University of Sydney, Erasmus MC, and DNDi to use an Open Pharma approach to discover compounds that could lead to new treatments for patients suffering from fungal mycetoma (eumycetoma), a devastating disease for which current treatments are ineffective, expensive, and toxic.
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.
[Kuala Lumpur/Geneva – 13 November 2017]
Malaysian pharmaceutical company Pharmaniaga Logistics Sdn Bhd (Pharmaniaga), Egyptian pharmaceutical company Pharco Pharmaceuticals (Pharco) and non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) have signed a collaboration agreement to manufacture and supply a new hepatitis C treatment regimen to be sold for US$300 in the public sector in Malaysia.
[Cape Town – 8 November 2017]
Non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) and the Global Antibiotic Research & Development Partnership (GARDP) today opened a new liaison office in Cape Town, South Africa.
[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.
[Español] [Français] [Português]
[Kuala Lumpur, Geneva – 20 September 2017]
Malaysia has issued a “government use” licence enabling access to more affordable versions of an expensive and patented medicine to treat hepatitis C. This landmark decision should help the more than 400,000 people living with hepatitis C in Malaysia access sofosbuvir, and could have important repercussions in the global effort to secure access to expensive treatments for this viral disease.
[Bahasa] [Español] [Português]
[Berlin – 4 September 2017]
Germany hosts pledging event for GARDP, a new initiative to develop new antibiotic treatments
Germany together with a number of countries and foundations today pledged EUR 56.5 million to help develop new treatments to fight against antibiotic resistance, during a fundraising event for the Global Antibiotic Research and Development Partnership (GARDP), hosted in Berlin by the German Federal Ministry of Health and the German Federal Ministry of Education and Research.
[Washington DC, Geneva – 31 August 2017]
On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.
[Geneva – 8 August 2017]
The Drugs for Neglected Diseases initiative (DNDi) announced today the appointment of Dr Marie-Paule Kieny as the new Chair of the Board of Directors. Dr Kieny, a former World Health Organization (WHO) Assistant Director-General, brings more than four decades of experience in public health and innovation to DNDi’s work in developing new treatments for neglected patients. Until July 2017, Dr Kieny led WHO’s Health Systems and Innovation cluster. During her career at WHO, she also led its Innovation, Information, Evidence and Research cluster, directed the WHO Initiative for Vaccine Research and led the organization’s activities on Ebola and Zika research, as well as the preparation of an R&D Blueprint to accelerate global preparedness for future pandemics. Before joining WHO in 2001, Dr Kieny was Director of Research at the Institute of Virology, Institut national de la Santé et de la Recherche médicale in Paris (INSERM) and Assistant Scientific Director of French biopharmaceutical company Transgene SA.