Anti-malaria drug approved by EMA

Eurartesim (dihydroartemisinin-piperaquine) has become the first artemisinin combination therapy (ACT) approved using a centralised procedure for use in Europe for the treatment of uncomplicated P.falciparum malaria.

The EMA granted regulatory approval for the treatment after a number of large-scale clinical trials that assessed Eurartesim’s safety and efficacy in comparison to artemether-lumefantrine or artesunate and mefloquine.

Marco Corsi, Medical Director of Sigma-Tau – who co-developed the treatments with Medicines for Malaria Venture (MMV), says trials “confirmed high cure rates, above 95%” for Eurartesim.

The drug is more patient friendly than other options and generally well-tolerated when administered once every three days. Clinical trials also demonstrated that when compared to other ACTs, Eurartesim provides better and longer protection from new malaria infections. 

The development of the regimen makes Sigma-Tau the first Italian company to be granted marketing authorisation for an anti-malarial drug by the 27 EU Member States from the EMA.

Almost 250 million people globally are affected by malaria, mainly in sub-Saharan Africa, where the disease kills more than 780,000 – 85% of whom are children under 5 years old.