Eurartesim(R) - dihydroartemisinin piperaquine (DHA-PQP) - the first artemisinin combination therapy (ACT) has been approved by the European Medicines Agency (EMA) for the treatment of uncomplicated malaria. Eurartesim was developed collaboratively by Sigma Tau Group, Italy, and the not-for-profit research foundation Medicines for Malaria Venture (MMV).
Eurartesim is now ready for delivery to Cambodia, the first malaria endemic country to place an order for the newly approved treatment. Cambodia prioritized the use of DHA-PQP as a first line drug and was awaiting EMA approval to allow procurement of this product using international donor funds.
The World Health Organization's standard treatment guidelines recommend DHA-PQP as a highly effective ACT in curing uncomplicated malaria. In early June, Sigma Tau submitted Eurartesim for pre-qualification by the World Health Organization, a process highly regarded by donors, and malaria-endemic countries, as an important measure of quality and efficacy of new drugs. In addition, Sigma Tau is about to submit the drug for registration in key African countries, e.g., Burkina Faso, Mozambique, Tanzania, Ghana and others.
Professor Trevor Jones of the Sigma-Tau Group Board of Directors commented, "Eurartesim represents a major innovation in the fight against the malaria. We are proud to announce that we continue to work towards achieving registration and distribution of the drug in malaria-endemic countries where thousands of people die each year from this disease. We are also ensuring its availability in Europe."
Although priority areas remain malaria-endemic countries, with marketing authorization from the EMA, Sigma Tau is planning to roll-out Eurartesim(R) across Europe, for use both by travelers to malaria-endemic countries and for imported cases of malaria in the case of returning travelers. Eurartesim is already available in France, UK, Germany, Belgium and Portugal, where the number of cases have been the highest in Europe.
Eurartesim was selected as the Medicines for Malaria Venture Project of the Year 2011, in recognition of its important contribution to the universe of quality-assured efficacious medicines for curing malaria.