Updates
April 2007
July 2007
registration status and how to get access at a ‘no profit-no loss price’
October 2008
21 October 2008
A lot has happened since we last updated you on the status of ASAQ, the artesunate-amodiaquine fixed-dose combination (Coarsucam®/ Artesunate Amodiaquine Winthrop®) developed together by DNDi and sanofi-aventis; and we want to make sure that you are aware of the most recent news!
What is status of ASAQ?
This month, ASAQ has been granted 'prequalified' status by the WHO Prequalification Program.
- ASAQ is the first fixed-dose combination (FDC) of the antimalarials, artesunate and amodiaquine, to be granted "prequalified" status by the WHO
- ASAQ is the first antimalarial FDC with a soluble formulation specifically designed for young children, to be granted "prequalified" status This status makes
- ASAQ is eligible for procurement of medicines by a larger number of countries and international agencies
- ASAQ joins Coartem as the only two FDC antimalarials on the "prequalified list"
- View the list on the WHO Prequalification website: http://healthtech.who.int/pq
Packaging for ASAQ has been improved for field use Earlier this year, and based on discussions with NGOs and the public sector, the blister packaging has been improved for ease of use by healthcare personnel and patients.
| |
Previous Blister Packaging |
New Blister Packaging |
| Infants |
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| Young children |
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| Children |
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| Adolescents/Adults |
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What is the profile of ASAQ?
 a very simple, age-based dosing regimen
- 1 tablet per day for 3 days for infants, children, and adolescents
- 2 tablets once a day for 3 days for adults
- Optimised dose ratio to avoid over- and under-dosage
soluble tablets specifically designed for young children
a commitment to make it available to all patients, right from the start
- <US$1 for adults and <US$0.50 for children in public markets
- Not patented
- First concrete result of an innovative partnership between a product development partnership (PDP) and a pharmaceutical firm
highest standards of quality enforced throughout the entire manufacturing process
Where is ASAQ?
The artesunate-amodiaquine fixed-dose combination has now been approved in 21 African countries.
Over 3 million treatments of ‘no-profit, no-loss’ ASAQ have been distributed into the field.
In 2008, ASAQ is reaching more and more patients, including at this MSF treatment programme in Guinea (pictured to the right).
Is there any recent clinical evidence on ASAQ?
Additional clinical data supporting the use of ASAQ has been presented at recent scientific meetings, including the XVIIth International Congress on Tropical Medicine and Malaria at Jeju, Korea, earlier this month:
In a multi-center, non-inferiority trial comparing ASAQ with Coartem® (fixed-dose artemether-lumefantrine) in Cameroon, Madagascar, Mali, and Senegal, ASAQ was shown to be as efficacious and well-tolerated as Coartem® (primary objective: 28-Day PCR-corrected parasitological and clinical cure rates was ≥95% in all arms) in a total of 941 patients including in 112 paediatric patients less than 5 years old. 1
The Phase III study carried out in Burkina Faso, comparing the fixed-dose ASAQ combination with the non-fixed AS+AQ association in 750 children less than 5 years old, with uncomplicated P. falciparum malaria, 28-Day PCR-corrected parasitological and clinical cure rate was ≥95% in both arms. 1
A clinical trial studying the drug’s tolerability and effectiveness in real-life conditions for its eventual registration in India has recently been concluded. The promising study results are consistent with previous studies with ASAQ in Africa, and support the consideration of ASAQ as first-line therapy in India where appropriate. 2
What are the plans for further study of ASAQ’s appropriate use?
DNDi, sanofi-aventis and additional partners are in the process of developing a comprehensive “ASAQ Deployment Monitoring Plan” that aims at collecting good quality data on ASAQ effectiveness and safety profile in “the field”. This program will be presented at the upcoming American Society of Tropical Medicine and Hygiene 57th Annual Meeting in New Orleans (December 7 – 11, 2008).
1. Doumbo O, Djimde A. Review of available clinical data on the ASAQ FDC - ATAQ EASY and Phase III Study in Burkina Faso. Presented at XVIIth International Congress on Tropical Medicine and Malaria (ICTM17), Jeju, Korea 2008.
2. Valecha N. Efficacy and safety of artesunate-amodiaquine fixed-dose combination in India. Presented at ICTM17, Jeju, Korea 2008.
November 2009
To be updated on ASAQ, please download the newsletter below:
newsletter_asaq_nov2009.pdf
April 2010
Updates on the status of ASAQ, the artesunate-amodiaquine fixed-dose combination (Coarsucam®/ Artesunate Amodiaquine Winthrop®) developed by DNDi and sanofi-aventis
WHAT IS STATUS OF ASAQ?
25 Million Treatments Distributed in Africa in 2009
- ASAQ is the first fixed-dose combination (FDC) of the antimalarials artesunate and amodiaquine to be granted "prequalified" status by the WHO
- ASAQ eligible for procurement of medicines by a larger number of countries and international agencies
- ASAQ joins Artemether-Lumefantrine as the only two FDC antimalarials on the "prequalified list"
- Application for inclusion of FDC ASAQ in the Essential Medicine List (EML) has been submitted to the 18th Expert Committee on the Selection and Use of Essential Medicines, to be held in Geneva in 2011 (www.who.int/selection_medicines/committees/expert/18/en/index.html)
WHAT IS THE PROFILE OF ASAQ?
a very simple, age-based dosing regimen
- 1 tablet per day for 3 days for infants (older than 2 months and weighting >4.5kg), children, and adolescents
- 2 tablets once a day for 3 days for adults
- Optimised dose ratio to avoid over- and –under-dosage
soluble tablets specifically designed for young children
a commitment to make it available to all patients, right from the start
- <US$1 for adults and <US$0.50 for children in public markets
- Not patented
- 1st concrete result of an innovative partnership between a product development partnership (PDP) and a pharmaceutical firm
| Artesunate Amodiaquine Fixed-dose Combination (2.7 AQ:AS ratio) |
| Maximum Acceptable
Supplier Sales Price
(per course of treatment,
in US$) |
Co-payment Amount
(per course of treatment,
in US$) |
| |
Hospital Pack |
Individual Pack |
Hospital Pack |
Individual Pack |
100/270mg
3x2 |
1.00 |
1.09 |
0.92 |
1.01 |
100/270mg
3x1 |
0.59 |
0.68 |
0.55 |
0.64 |
50/135mg
3x1 |
0.39 |
0.47 |
0.37 |
0.45 |
25/67.5mg
3x1 |
0.30 |
0.38 |
0.29 |
0.37 |
Taken from www.theglobalfund.org/documents/amfm/AMFmFAQs_en.pdf
highest standards of quality enforced throughout the entire manufacturing process
Where is ASAQ?
The artesunate-amodiaquine FDC has now been approved in 25 African countries and in India
Over 50 million treatments of ASAQ have been distributed in 24 countries in Africa, with 50% of treatments for infants
Is there any recent clinical evidence on ASAQ?
Clinical field evaluation of the new ASAQ FDC, compared with the non-fixed AS+AQ combination, was done in babies and young children suffering uncomplicated malaria (N=750). 1
Population pharmacokinetic (PK) and clinical assessment of ASAQ FDC, compared with the non-fixed AS+AQ combination, were performed in children in Burkina Faso (N=140) and adults in Kenya (N=50), suffering uncomplicated malaria. 2-3
Multi-country, clinical comparison of ASAQ FDC with arthemeter/lumefantrine, the already available fixed-dose combination of artemether/lumefantrine. In 940 patients affected by uncomplicated malaria in Cameroon, Mali, Madagascar and Senegal, including 54 % of patients aged over 5 years, among which 174 patients older than 14 years old, the new ASAQ FDC was compared to arthemeter/lumefantrine. ASAQ administered either once a day or twice a day was also compared. (ASAQ N=629). 4
Evaluation of the use of the AS and AQ combination (both fixed and non-fixed) in all reported studies in sub-Saharan Africa resulted in two multi-centre analysis (per study and individual patient data) and supports the use of the combination in a number of African countries. A comprehensive field assessment of the safety of the non-fixed combination of AS plus AQ in patients with parasitological confirmed P. falciparum malaria was also performed in Senegal, over the period of 2000 to 2005. A larger Senegalese assessment (N=3277) of AS + AQ was presented at the 2007 annual meeting of the American Society of Tropical Medicine and Hygiene, in Philadelphia, Pennsylvania, USA, and published in 2009. 5-10
1. Sirima S, Tiono A, Gansané A, Diarra A, Ouédraogo A, Konaté A, Kiechel JR, Morgan C, Olliaro P and Taylor W. The efficacy and safety of a new fixed-dose combination of amodiaquine and artesunate in young African children in Burkina Faso with acute uncomplicated Plasmodium falciparum. Malaria J 2009, 8:48
www.malariajournal.com/content/pdf/1475-2875-8-48.pdf
2. Stepniewska K, Taylor W, Sirima S, Ouedraogo E, Ouedraogo A, Gansané A, Simpson J, Morgan C, White N and Kiechel JR. Population pharmacokinetics of artesunate and amodiaquine in African children. Malaria J 2009, 8:200
www.malariajournal.com/content/pdf/1475-2875-8-200.pdf
3. Ogutu B, Juma E, Jullien V, Carn G, Kiechel JR. Safety, efficacy and pharmacokinetic comparison of fixed-dose artesunate amodiaquine “ASAQ” with non-fixed dose combination of AS and AQ among Kenyan adults. Presented at the ASTMH 2009 in New Orleans during the session of Malaria-Drug Development.
www.astmh.org/Meeting_Archives.htm
4. Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa A, Forlemu D, Moor VA, Traore A, Niawanlou Dara YD, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O: 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 J 2009, 8:125
www.malariajournal.com/content/pdf/1475-2875-8-125.pdf
5. Olliaro P, Vaillant M, Zwang J, Harhay M, on behalf of the AS&AQ Group. Efficacy & safety of artesunate-amodiaquine (AS&AQ) for treating uncomplicated falciparum malaria in Sub-Saharan Africa: A systematic review with Aggregate (APD) & Individual Patient (IPD) Meta-Analyses. Poster presented at the ASTMH 2008 in New Orleans
6. Olliaro P, Vaillant M, Phalkey R, Guthmann JP, Dorsey G, Brasseur P, D’Alessandro U, Millet P, Taylor B. Artesunate + amodiaquine (AS+AQ) for the treatment of uncomplicated falciparum malaria: An inventory and systematic review of safety and efficacy data. Am J Trop Med Hyg. 2006; 75(Supp5):89.
www.ajtmh.org/cgi/reprint/75/5_suppl/76
7. Zwang J, Olliaro P, Barennes H, Bonnet M, Brasseur P, Bukirwa H, Cohuet S, D'Alessandro U, Djimdé A, Karema C, Guthmann JP, Hamour S, Ndiaye JL, Mårtensson A, Rwagacondo C, Sagara I, Same-Ekobo A, Sirima S, van den Broek I, Yeka A, Taylor W, Dorsey G and Randrianarivelojosia M. Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis. Malaria J 2009, 8:203
www.malariajournal.com/content/pdf/1475-2875-8-203.pdf
8. Brasseur P, Agnamey P, Gaye O, Vaillant M, Taylor WR, Olliaro PL. Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal. Malaria J 2007;6:150
www.malariajournal.com/content/pdf/1475-2875-6-150.pdf
9. Brasseur B, Agnamey P, Gaye O, Vaillant M, Taylor WRJ, Olliaro PL. Monitoring the efficacy and safety of Artesunate plus Amodiaquine (AS+AQ) over 6 years using the WHI in vivo protocol and a simple pharmacovigilance study in the district of Oussouye, Cassamance, Southern Senegal
www.astmh.org/meetings/07abstract/pages_150-199.pdf
10. Brasseur P, Agnamey p, Gaye O, Cisse M, Badiane M, Vaillant M, Taylor W and Olliaro P- Dosing accuracy of artesunate and amodiaquine as treatment for falciparum malaria in Cassamance, Senegal-Trop Med Int Health 2009;14(1):79-87 AS and AQ have been used, separately and together, to treat P. falciparum malaria for a number of decades. Scientific evidence supporting their combined administration derives from studies in which these drugs have been given in non-fixed-dose combination or co-blister formulations to more than 10,000 patients in more than 19 countries and, more recently, in the new FDC. ASAQ FDC has been used in clinical studies starting in 2005. The number of patients having taken the fixed-dose combination since 2005 in clinical studies is more than 2000.
Current activities on the field
sanofi-aventis partners with National Malaria Control Programmes
Partenariats avec les Programmes Nationaux de Lutte contre le Paludisme
An innovative partnership between sanofi-aventis and the NGO "Jeremi" in Burkina Faso
Un partenariat innovant entre sanofi-aventis et l’ONG Jeremi au Burkina Faso
"Schoolchildren against malaria": raising awareness through drama
"Ecoliers contre le paludisme" : sensibiliser les enfants à travers le théâtre
Summary of Product Characteristics for ArteSunate AmodiaQuine Winthrop ®
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