Mumbai-based Cipla, along with the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) announced the prequalification of the fixed dose combination (FDC) of Artesunate (AS) and Mefloquine (MQ) – ASMQ FDC – by the World Health Organization (WHO). This Cipla-manufactured ASMQ FDC available in India under the brand name ‘MEFLIAM Plus’ is the first Artesunate-Mefloquine FDC to be prequalified by WHO and is recommended for the treatment of malaria.
“The prequalification announcement is recognition that MEFLIAM Plus meets WHO’s high quality standards and we aim to make this treatment widely available throughout Asia,” commented Dr Jaideep Gogtay, Medical Director, Cipla.
“The availability of ASMQ FDC will have a direct impact on patients, especially in Asia. It addresses an important public health need in the region as it forms part of the malaria treatment arsenal necessary to control the disease,” said Bernard Pécoul, Executive Director, DNDi.
This combination of AS and MQ is one of five Artemisinin Combination Therapies (ACTs) currently recommended by WHO for the treatment of uncomplicated P falciparum malaria, and is the first-line treatment in a number of South East Asian countries. ASMQ FDC was registered in India in 2011 and in Malaysia in early 2012. In India, about 18,000 adult patients have already been treated with MEFLIAM Plus.
ASMQ FDC was originally developed by DNDi and the Brazilian government-owned pharma company Farmanguinhos/Fiocruz and was registered in Brazil in 2008. A South-South technology transfer between Farmanguinhos and Cipla was achieved in 2010 to facilitate the implementation of ASMQ FDC in Asia. Prequalification is a major milestone, as it indicates that ASMQ FDC meets WHO standards of quality, safety, and efficacy.
In addition to being easy to use (a single daily dose of one or two tablets over three days), MEFLIAM Plus will increase patient compliance and contribute to reducing the risk of resistance development, as it ensures both drugs are taken together and in correct proportions (four dosage forms based on age/ weight dosing).
Scientific evidence supporting the development of ASMQ FDC derives from the well-established use of their combined administration, as demonstrated by clinical data including more than 11,000 patients. In 2009, a study in Myanmar comparing the effectiveness of the four fixed-dose ACTs, then recommended by WHO, showed that ASMQ FDC had the highest cure rate and the lowest rate of gametocyte carriage, providing the greatest post-treatment suppression of recurrent P falciparum malaria and the most effective suppression of blood-stage P vivax malaria.
The MEFLIAM Plus is manufactured in Cipla’s world class manufacturing facility in Patalganga, India, which is approved by WHO-Geneva, US FDA, MHRA-UK and various other regulatory bodies.
A prequalified status makes MEFLIAM Plus eligible to tenders that receive funding from international procurement agencies, such as UNICEF and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
EP News Bureau