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Malaria treatment approved for use by the European Medicines Agency

3 November 2011

Eurartesim®, an artemisinin combination therapy, has been approved by the European Commission for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum. Wellcome Trust-funded research played a key part in the early development of this combination drug.

The drug Eurartesim® began as a collaboration between Chinese researchers and Oxford University-based researchers in Thailand, Vietnam and Laos. It was developed by the nonprofit foundation Medicines for Malaria Venture (MMV) and pharmaceutical company Sigma-Tau. Registration of the drug marks the final stage of its research and development.

The combination of dihydroartemisinin and piperaquine, the two active ingredients of Eurartesim®, has been widely used over the past decade and is one of the most widely investigated artemisinin combination therapies. It is effective in treating clinical malaria and provides longer protection against reinfection than some other combination therapies.

Countries where malaria is widespread have not always been able to get the drug using donor funds, however, because of the lack of approval by a stringent regulatory body. The recent approval should mean that thousands more people with malaria can receive this treatment.

The formal assessment of the combination of dihydroartemisinin and piperaquine began as a collaboration between Professor Li Guo Qiao (Guangzhou, China) and Professor Tran Tinh Hien, based at the Hospital for Tropical Diseases (HTD) and the Wellcome Trust Major Overseas Programme in Vietnam.

The first formal randomised controlled study was undertaken at HTD and published in the 'Lancet' in 2004. This study found the combination to be "an inexpensive, safe, highly efficacious fixed-dose antimalarial combination treatment that could make an important contribution to the control of multidrug-resistant falciparum malaria".

Researchers started to investigate the use of piperaquine in combination with artemisinin-based compounds and other antimalarial drugs in the late 1990s. This followed a remarkable series of combination therapies developed for malaria called 'CV4' (China-Vietnam drug number 4) and 'CV8' (which contained dihydroartemisinin and piperaquine but also trimethoprim and primaquine). Finally, the combination of dihydroartemisinin and piperaquine was settled upon and subsequently developed by MMV and Sigma-Tau as Eurartesim®.

Professor Hien, the lead researcher in the initial studies, said: "It is so gratifying to see this combination treatment being approved by the European Commission. I just wish it had happened quicker. When we started studying this combination, we had no idea just how effective and well tolerated it would prove to be.

"The whole history of the development of the artemisinin compounds is a lesson for drug development and shows the importance of academic clinical research. It would not have been possible without taking risks and the flexible support of the Hospital for Tropical Diseases and the Wellcome Trust. I wonder if we could do this sort of world-changing research now? I hope so!"

Professor Nicholas White, who led the subsequent dose funding and clinical trials in Thailand, Laos and Indonesia that paved the way for the licensing of this combination therapy, said: "Dihydroartemisinin and piperaquine has fulfilled its early promise and is set to become one of the most important antimalarial drugs in the world."

In a letter to colleagues, David Reddy, CEO of MMV, said that the drug will now be submitted to WHO's Prequalification Programme for approval. He adds that this additional approval will accelerate acceptance by national regulatory authorities in countries where malaria is endemic.

Image: Artemisia annua (sweet wormwood), the source of artemisinin. Credit: Rowan McOnegal, Wellcome Images.

References

Tran TH et al. Dihydroartemisinin-piperaquine against multidrug-resistant Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet 2004;363(9402):18-22.

Ashley EA et al. Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. J Infect Dis 2004;190:1773-82.

Ashley EA et al. A randomized controlled study of a simple once daily regimen of dihydroartemisinin-piperaquine for the treatment of uncomplicated multi-drug resistant falciparum malaria. Clin Infect Dis 2005;41:425-32.

Mayxay M et al. A phase III, randomized, non-inferiority trial to assess the efficacy and safety of dihydroartemisinin-piperaquine in comparison with artesunate-mefloquine in patients with uncomplicated Plasmodium falciparum malaria in southern Laos. Am J Trop Med Hyg 2010;83:1221-9.

Valecha N et al. An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia. PLoS One 2010;5:e11880.

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