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DNDi Achievements

Artesunate + amodiaquine (ASAQ) to treat malaria Malaria

Short-course fixed-dose combination for easier administration

2007

 

Affordable, fixed-dose drug combination simplifies malaria treatment

With older antimalarial medicines increasingly ineffective due to growing drug resistance, in 2001 WHO recommended the use of artemisinin-based combination therapies as first-line malaria treatment.

However, there were no combinations of the recommended drugs. This meant that people had to take each drug in separate tablets – complicating administration and increasing the likelihood of drug resistance developing due to people not taking the full and correct dose of both medicines.

The dispersible, fixed-dose combination of artesunate and amodiaquine (ASAQ) requires only one dose per day for three days, reducing the “pill burden” for both adults and children. It is also easier to administer to infants and young children because it dissolves in water. A dual-aluminium blister packaging ensures a three-year shelf-life, even in a tropical environment.

ASAQ was developed as a public good, so it is affordable and has no patents, making it available for production by any generic drug manufacturer that meets quality standards.

At a glance

  • Indication: Malaria
  • Dosage: Single daily fixed-dose combination of artesunate & amodiaquine for 3 days
  • Project start: 2002

 

Impact

  • Registered in 35 countries and territories since 2007
  • More than 516 million treatments distributed since 2007
  • First registered in Morocco to enable rapid exportation to other African countries
  • No patent: Developed as a public good, so any generic company meeting quality standards can produce it
  • Technology transfer to Zenufa (Tanzania)
  • Five different manufacturers’ ASAQ products are now prequalified by WHO
  • Handed over to Medicines for Malaria Venture access team in 2015 for continued implementation
  • Released at a cost of only US $0.50 for children, US $1.00 for adults

History – the FACT project

In response to WHO’s recommendation of artesunate combination therapies to treat malaria, Médecins Sans Frontières, the WHO Special Programme for Research and Training in Tropical Diseases, and other partners established the Fixed-Dose-Artesunate Combination Therapy (FACT) project in 2002. When DNDi was created in 2003, it took over management of the FACT project.

FACT’s objective was to develop two fixed-dose combination therapies containing artemisinin for the treatment of malaria. The urgency of these goals was confirmed by WHO’s 2006 malaria treatment guidelines calling for an immediate halt to artemisinin monotherapy, to prevent the creation of drug resistance. ASAQ was first released in 2007.

 

“This new fixed-dose combination has been adapted to patients’ needs by being simple to use, more affordable, and a quality product. The fact that ASAQ was made so affordable right from the start and is not under patent removes a significant barrier to its availability and should serve as a model for future drug development for neglected diseases.”

Dr Bernard Pécoul, Executive Director, DNDi

 

Key scientific articles

The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data. BMC Medicine, March 2015
by The Worldwide Antimalarial Resistance Network (WWARN) AS-AQ Study Group including Diap G, Kiechel JR, Sharma B.

Fixed dose artesunate amodiaquine – a phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine. Malaria Journal, December 2014
by Ogutu B, Juma E, Obonyo C, Jullien V, Carn G, Vaillant M, Taylor WRJ, Kiechel JR.

Plasmodium falciparum clearance in clinical studies of artesunate-amodiaquine and comparator treatments in sub-Saharan Africa, 1999–2009. Malaria Journal, March 2014
by Zwang J, Dorsey G, Mårtensson A, d’Alessandro U, Ndiaye JL, Karema C, Djimde A, Brasseur P, Sirima SB, Olliaro P.

Efficacy of ASAQ and AL fixed-dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria among children aged six to 59 months in Nimba County, Liberia: an open-label randomized non-inferiority trial. Malaria Journal, July 2013
by Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, Pinoges L, Sundaygar T, Zolia YM, Jones JJ, Comte E, Bruneel A, Branger M, Jullien V, Carn G, Kiechel J, Ashley EA, and Guérin PJ.

Tolerability and safety of ASAQ and AL fixed dose combinations for the treatment of uncomplicated Plasmodium falciparummalaria: two open-label, randomized trials in Nimba County, Liberia.Malaria Journal, July 2013
by Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, Pinoges L, Sundaygar T, Zolia YM, Jones JJ, Comte E, Bruneel A, Branger M, Jullien V, Carn G, Kiechel JR.

Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Malaria Journal, June 2009
by Ndiaye J-L, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa, Forlemu D, Moor VA, Traore A, Dicko Y, Dara N, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O.

See all ASAQ publications

Press releases

News

 

Partners

Sanofi, France; MMV, Switzerland; AEDES, Belgium; Zenufa, Tanzania; National Centre for Research and Training on Malaria, Burkina Faso; Universiti Sains Malaysia; Oxford University, UK; Institute of Research for Development (IRD), Senegal; Université de Bordeaux Faculté de Pharmacie, France; Mahidol University, Thailand; Bertin Pharma, France; Médecins Sans Frontières; Epicentre, France; WHO-TDR; Kenya Medical Research Institute (KEMRI), Kenya; Indian Council of Medical Research (ICMR), India; National Malaria Control Programme, Ministry of Health, Burundi; Ministry of Health, Sierra Leone; Ministry of Health, Ghana; Komfo Anokye Teaching Hospital (KATH), Ghana.

Funding

Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; European Union – Specific International, Scientific Cooperation Activities (INCO); French Development Agency (AFD), France; Global Fund – AmFM, Switzerland; Médecins Sans Frontières/Doctors without Borders, International; Médecins Sans Frontières, Italy; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

 

Photo credit: FBBVA

Last updated: October 2018