Malaria treatment approved for use by the European Medicines Agency

Eurartesim®, an artemisin 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 pharamaceutical 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 last 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.

Researchers first started to investigate the use of piperaquine in combination with artemisinin-based compounds and other anti-malarial drugs in the 1990s. Subsequent research - much of it supported by the Wellcome Trust in its South-east Asia Major Overseas Programme and taking place in Vietnam, Thailand, Laos and Indonesia - identified the combination of piperaquine and dihydroartemisinin as a highly effective and well-tolerated treatment.

This work includes a pilot randomised study in Vietnam (published in the 'Lancet' in 2004), dose-finding and pharmacology studies in Thailand, and later large definitive clinical trials in Thailand and Laos.

Professor Nicholas White, who led the academic component of the collaborative project, 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.

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