ASAQ Winthrop® (artesunate-amodiaquine) for the treatment of acute uncomplicated malaria

According to the WHO, malaria affected 228 million people worldwide in 2018, resulting in 405,000 deaths. Timely access to the appropriate treatment is key to ensuring a bout of acute uncomplicated malaria does not turn into a case of severe malaria. 

ASAQ: an ACT recommended by WHO for the treatment of acute uncomplicated malaria 

Artesunate-amodiaquine is one of five ACTs recommended by WHO for the treatment of acute uncomplicated P. falciparum malaria. The first fixed-dose combination of artesunate-amodiaquine (ASAQ), developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi and branded ASAQ Winthrop, was prequalified by WHO in 2008. Since then, ASAQ has played an important role in the global effort to improve timely access to treatment. 

3-day treatment accessible in 33 countries for a low price 

ASAQ Winthrop has been approved in 33 countries and over 537 million treatments have been distributed since 2007. The product is administered once per day, for 3 days. In general, ASAQ is the lowest-priced of the fixed-dose ACT combinations procured by the Global Fund and public-sector procurement partners. 

Detecting rare adverse events in "real-life" settings  

As part of its risk management plan following the launch of ASAQ, Sanofi agreed to work with MMV and DNDiin the conduct of a large phase IV study in Côte d’Ivoire, designed to detect rare adverse events in "real-life" settings (affecting 1 patient or fewer in every 5,000 treated). In 2016, the formal results of this study were presented to stakeholders in Côte d’Ivoire, and the results were published in Malaria Journal in 2017.1,2  The study concluded that ASAQ for the treatment of uncomplicated P. falciparum malaria under real-life conditions in Côte d’Ivoire is well tolerated, and emphasized the role of properly trained community health workers to collect pharmacovigilance data in the field to document rare adverse events.   

MMV supports access to ASAQ in malaria-endemic countries 

Through an agreement with DNDi in 2015, MMV agreed to take over access stewardship of ASAQ. This involves supporting its use in endemic countries as per its recommended label and helping disseminate evidence-based information regarding its efficacy and safety for consideration by national treatment programmes, in line with WHO’s guidance. 

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    Past and current partners:

    DNDi, Sanofi


     

    1. Assi SB et al. Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d'Ivoire. Malaria Journal. 16(1):8 (2017). 

    1. Assi SB et al. Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Côte d'Ivoire. Malar Res Treat. 2017;2017:3958765

     

    Updated February 2021