# \[e-drug\] MSF calls AMFm to endorse FDCs of ACT

**URL:** <https://talk.edrugplus.org/t/e-drug-msf-calls-amfm-to-endorse-fdcs-of-act/31227>\
**Category:** e-drug\
**Created:** [February 2, 2009, 4:22pm UTC](https://talk.edrugplus.org/t/e-drug-msf-calls-amfm-to-endorse-fdcs-of-act/31227 "2009-02-02T16:22:56Z")\
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**Author:** ![Leyla\_Pope](https://avatars.discourse-cdn.com/v4/letter/l/c0e974/32.png) [@Leyla\_Pope](https://talk.edrugplus.org/u/Leyla_Pope)\
**Post date:** [February 2, 2009, 4:22pm UTC](https://talk.edrugplus.org/t/e-drug-msf-calls-amfm-to-endorse-fdcs-of-act/31227/1 "2009-02-02T16:22:56Z")

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E-DRUG: MSF calls AMFm to endorse FDCs of ACT  
---------------------------------------------

AMFm: Affordable Medicines Facility malaria

Dear e-druggers,

In view of the imminent launch of the AMfm, MSF has written to the Global  
Fund to ask that the AMfm endorse the exclusive use of fixed-dose  
combinations of artemisinin-based combination therapies (ACT).

The text of the letter has been pasted below, or to download MSF's letter  
to the Global Fund click on the following link:  
[http://www.msfaccess.org/fileadmin/user\_upload/diseases/other\_diseases/msfletter\_FDC\_jan09.pdf](http://www.msfaccess.org/fileadmin/user_upload/diseases/other_diseases/msfletter_FDC_jan09.pdf)

January 27, 2009

Dear Dr. Kazatchkine,

Medecins Sans Frontieres (MSF) welcomes the imminent launch of the  
Affordable Medicines Facility for malaria (AMFm).

We would like to take this opportunity to recommend that the AMFm  
exclusively endorses fixed-dose combinations (FDCs) of artemisinin-based  
combination therapies (ACT).

The advantages of using FDCs have been well documented in several disease  
areas, including tuberculosis and HIV/AIDS. 1 2 3 An FDC can benefit  
patients by reducing the pill burden, thereby increasing adherence.  
Additionally, combining therapies within a fixed-dose prevents the risk of  
medication being taken as monotherapy. FDCs are thus useful both when  
considering a patient's needs, as well as on the broader spectrum of  
reducing the risk of resistance development. As you may know, the WHO Roll  
Back Malaria (WHO/RBM) recommends the use of FDCs for malaria treatment.

To date, there are two WHO prequalified (WHO-PQ) co-formulations of  
arthemeter/lumefantrine (Novartis, Ajanta) and others are under assessment.  
There is only one WHO-PQ artesunate/amodiaquine FDC (sanofi-aventis) but  
three further products are under assessment. Two FDCs containing  
artesunate/mefloquine are under assessment by the WHO-PQ programme.

One can therefore assume that in the near future there will be two or more  
WHO pre-qualified FDCs for each of these key ACTs. The growing number of  
manufacturers of artemisinin-containing FDCs thus provides a viable way for  
the AMFm to use FDCs exclusively from the outset while ensuring sufficient  
generic competition.

Furthermore, the AMFm technical proposal has already outlined its  
acceptance, under certain conditions 4, of non-WHO PQ products for a period  
of two years. In addition, if the situation arises where there are not  
enough FDC formulations available, a time-limited acceptance of  
co-blisters, similar to the time-limited acceptance of non WHO-PQ products,  
could be considered.

We believe that by endorsing the exclusive use of FDCs, the AMFm will give  
a clear message to manufacturers to invest in the development of such  
formulations, including all necessary quality, safety and efficacy  
elements.

Such a move would also encourage the WHO Prequalification Programme to  
consider the review of FDCs as a priority.

An acceptance of co-blisters beyond a limited timeframe, however, would  
only discourage potentially interested manufacturers from developing FDCs.

We hope these comments make a constructive contribution to the AMFm and  
look forward to discussing the issue further with you.

Yours sincerely,

Tido von Schoen-Angerer, MD  
Executive Director  
Campaign for Access to Essential Medicines  
Medecins Sans Frontieres International

1. Connor J, Rafter N, Rodgers A: Do fixed-dose combination pills or  
unit-of-use packaging improve adherence? A systematic review. Bull World  
Health Organ 2004;82:935-9

2. Moulding T, Dutt AK, Reichman LB. Fixed-dose combinations of  
antituberculous medications to prevent drug resistance. Ann Intern Med  
1995;122:951-954

3. Laurent C: Effectiveness and safety of a generic fixed-dose combination  
of nevirapine, stavudine and lamivudine in HIV-1-infected adults in  
Cameroon: open-label multicentre trial. Lancet 2004; 364:29-34

4. If there are \< 2 or 3 products already WHO-PQ or authorized for use by  
a Stringent Regulatory Authority (SRA), if such products are manufactured  
in a site GMP compliant certified after inspection by WHO or by a SRA for  
the formulation concerned, and the product dossier accepted for review by  
WHO-PQ or SRA, and recommended for use by an ad-hoc expert review panel  
(ERP).  
Information from: AMFm Taskforce of the Roll Back Malaria Partnership:  
Interim report on progress against outstanding AMFm implementation  
challenges. (February 2008)

Leyla Pope  
Communications Officer  
Medecins Sans Frontieres  
Campaign for Access to Essential Medicines  
Tel. + 41(0) 22 849 89 88