• DNDi project manager and coordinator: Jean-René Kiechel, Gwenaëlle Carn
• Project start: January 2002

Status: ASAQ, the new fixed-dose combination (FDC) of artesunate (AS) and amodiaquine (AQ), was the first drug to be made available by DNDi in a partnership with sanofi-aventis. Now available in 24 countries in sub-Saharan Africa and in India, with over 25 million treatments ordered in 2009, the continuing focus of this post-registration project is to support sanofi-aventis’ implementation of ASAQ for the treatment of uncomplicated falciparum malaria after its registration in endemic countries, mainly in sub-Saharan Africa and India.

ASAQ provides a true innovation in patient treatment by being a tropical-stable bilayer co-formulation, which allows AS and AQ to be taken together and in the correct proportions in a simplified three-day dosing regimen where the most vulnerable population, children under the age of five, take one tablet per day.

DNDi, sanofi-aventis and additional partners, in particular MMV and National Malaria Control Programmes, are implementing a comprehensive “ASAQ Field Monitoring Programme” that aims to collect high-quality data on ASAQ effectiveness and safety profile in “the field”. This programme includes a series of proactive clinical studies conducted in several countries of sub-Saharan Africa with different levels of disease transmission.

Key ongoing studies include two post-registration studies being done in collaboration with MSF, Epicentre, and the National Malaria Control Programme in Liberia. In Ivory Coast, two clinical studies are being set up in collaboration between sanofi-aventis, MMV, and DNDi. Ultimately, more than 20,000 patients will be followed as part of this monitoring plan. The field monitoring programme as well as additional clinical data supporting the use of ASAQ has been presented at international meetings such as ASTMH 2008 and the 3rd Annual East African Health Sciences in March 2009.