WHO Prequalifies Indian Malaria Drug
A new artemisinin-based malaria drug produced by Indian pharmaceutical company Cipla has been prequalified by the World Health Organization (WHO).
AsianScientist (Oct. 15, 2012) – A new artemisinin-based malaria drug produced by Indian pharmaceutical company Cipla has been prequalified by the World Health Organization (WHO).
The Cipla-manufactured fixed dose combination (FDC) of Artesunate (AS) and Mefloquine (MQ) is the first artesunate-mefloquine FDC (ASMQ FDC) to be prequalified by WHO and is recommended for the treatment of malaria.
Prequalification is a major milestone, as it indicates that the drug meets WHO standards of quality, safety, and efficacy.
“The prequalification announcement is recognition that ASMQ FDC meets WHO’s high quality standards and we aim to make this treatment widely available throughout Asia,” said Dr. Jaideep Gogtay, Medical Director, Cipla.
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 this combination.
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.
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 prequalification announcement was made jointly by Cipla and the Drugs for Neglected Diseases initiative (DNDi) earlier this month.
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