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ASAQ Registration Update

April 2007: In keeping you periodically updated on the status of the artesunate-amodiaquine fixed-dose combination (“ASAQ”) developed together  by DNDi and sanofi-aventis, we are taking the opportunity to both update you on ASAQ registration status and to thank you for support of and participation in our launch events and briefings.

The registration process in Morocco, where ASAQ is produced, was undertaken by sanofi-aventis in December 2005, with approval granted on 1 February 2007. ASAQ was submitted for registration in 23 sub-Saharan African countries and is currently registered in 12 of these countries: Benin, Burkina Faso, Congo, Côte d’Ivoire, Gabon, Guinea, Kenya, Mali, Mauritania, Democratic Republic of the Congo, Togo and Zanzibar.

ASAQ has also entered the WHO prequalification process, with a dossier submission in February 2007. As part of the prequalification process, WHO plans to inspect the Moroccan production facility in June 2007.

On 30 January 2007, independent experts, who were appointed by Médecins Sans Frontières, carried out a GMP inspection of the Moroccan production facility and made no “critical” findings. The final report will be communicated to UNICEF/WHO.

Six years after the artesunate & amodiaquine combination was recommended for Africa by the WHO, the first high-quality AS-AQ fixed-dose combination is now available.

Introducing the FACT Project

In 2001, the World Health Organization recommended the use of artemisinin-based combination therapies (ACTs), which are currently extremely effective against malaria, but have not been widely implemented due to cost and availability issues.

To address the need for new effective malaria medicines, DNDi established the “FACT Project” for malaria in 2002, in association with Médecins Sans Frontières (MSF), the INCO-DEV programme of the European Union, and the UNICEF-UNDP-World Bank-WHO’s Special Programme for Research and Training in Tropical Diseases (WHO/TDR).

The goal of the project was to develop two effective, safe, viable, affordable, and field-adapted fixed-drug combinations (FDCs) as quickly as possible - artesunate-amodiaquine (AS/AQ) and artesunate mefloquine (AS/MQ).

The FACT Project brings together academic, public and private partners in developing and developed countries who contribute both in cash (through direct financing) and kind (expertise, facilities etc.).

DNDi has also teamed up with industrial partners to ensure the timely development of these two FDCs, so that they are ready for registration in 2007. With sanofi-aventis, DNDi aims to manufacture AS/AQ at a target price of less than USD1 for adults and 50 cents for children, a cost more affordable than existing ACTs.  With FarManguinhos, Brazil, and an industrial partner in Asia, DNDi aims to manufacture AS/MQ at a target price of $2-2.5 per adult treatment.

Treating infants and children is a critical need, yet no paediatric formulation of an ACT exists. For this reason, both FDCs will also be made available in formulations suited to infants, children, and teenagers.

The FDCs will be simple to use: a single daily administration of one or two tablets (paediatric or adult) for three days. The advantages are proven and manifold:

  • Rapid effect
  • High cure rate (over 90%)
  • Reduction of transmission potential (less infective parasites in the blood)
  • Easy to use – fewer tablets to swallow, less often (which increases compliance and therefore treatment effectiveness)
  • Coverage of whole population at risk (treatment can be used in both children and adults)
  • Cheaper than buying a combination of separate tablets or blister pack.
DNDi’s non-patented ACTs will offer patients and doctors in malaria-endemic countries a wider range of treatment options adapted to their needs. The FACT Project provides an encouraging example of different global stakeholders working effectively to meet global health needs.


New Hope for Malaria Patients in 2006


Background on combination therapies:

ACT Global Strategy (march 2006)

ACT Implementation progress (by 2005)

Read the press release about DNDi's announcement at 54th annual American Society of Tropical Medicine and Hygiene (ASTMH) Conference.






Other Related Articles

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DNDi's Portfolio Map, January 2007

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ASAQ Registration Update

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DNDi’s therapeutic areas

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DNDi: Matching needs and opportunities

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Identifying patient needs

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Project management


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