In April 2005, Sanofi and DNDi formed a public-private partnership with the goal of developing a non-patented fixed-dose combination of artesunate-amodiaquine to better meet the patients’ needs, specifically those of children. DNDi developed the formulation combining two active ingredients in a single tablet and carried out the initial pharmaceutical and clinical development. Sanofi developed the product, carried out additional clinical studies, prepared the dossier for regulatory authorities and applied for WHO prequalification. The new treatment is simpler (1 or 2 tablets once a day) than the existing ones and dissolves in water, which makes it suitable for children.
The medicine is sold at a preferential prices, including “no profit no loss” prices, to governments of endemic countries, NGOs, and major sponsors such as UNITAID and the Global Fund. It is now registered in 33 countries and at the end of 2013, more than 277 million treatments were distributed.
In addition, an innovative Risk Management Plan (RMP) was designed by the partners to provide high-quality information on the safety and efficacy on this drug. This RMP comprises 23 clinical studies in 19 countries, primarily set-up in Africa, each of which documenting different aspects of ASAQ Winthrop safety and efficacy. It is expected that over 20,000 patients will be included in this RMP, which is the first such program to be submitted to the WHO. It is expected that this initiative will help build capacity in pharmacovigilance in sub-Saharan Africa, using narrowly-tailored methods of data collection on the safety and efficacy of medicines when they are used in “real life” situations.
|Location||East Asia and Pacific, Zambia, Uganda, Tanzania, Senegal, Nigeria, Mozambique, Mali, Malawi, Kenya, Indonesia, India, Ghana, Gabon, Cote d Ivoire, Congo, The Republic of, Congo, The Democratic Republic of, Colombia, Chad, Cameroon, Cambodia, Burkina Faso, Brazil, Benin, South Asia, Latin America and Caribbean, Eastern Africa|