ASAQ Winthrop® (artesunate-amodiaquine)

The first fixed-dose combination of the ACT artesunate-amodiaquine (ASAQ), developed by DNDi and Sanofi and branded ASAQ Winthrop®, was prequalified by WHO in 2008. As one of five ACTs recommended by WHO for the treatment of uncomplicated malaria, ASAQ has an important role to play in the global effort to improve timely access to treatment.

The product is administered once per day, for 3 days duration. ASAQ Winthrop has been approved in 33 countries and over 516 million treatments distributed since 2007. In general, ASAQ is the lowest-priced of the fixed-dose ACT combinations procured by the Global Fund and public-sector procurement partners.

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

 
  • Access in Action

    • As part of its risk management plan following the launch of ASAQ, Sanofi agreed to work with MMV and DNDi in the conduct of a large phase IV study in Côte d’Ivoire, designed to detect rare adverse events (1 in 5,000) inpatients receiving ASAQ in “real-life” settings. 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.

     


    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 January 2019