Marketing authorization for Eurartesim® announced at media roundtable

This fixed-dose combination of dihydroartemisinin and piperaquine is administered once a day for 3 days

30 Nov 2011

For the very first time, the European Medicines Agency (EMA), using a centralised procedure, has granted regulatory approval to an artemisinin combination therapy (ACT) for the treatment of uncomplicated P. falciparum malaria. This ACT, Eurartesim® (dihydroartemisinin-piperaquine), was developed collaboratively by Sigma-Tau s.p.a Industrie Farmaceutiche Riunite, Italy, and the not-for-profit product development partnership Medicines for Malaria Venture (MMV). The development of Eurartesim has made Sigma-Tau the first Italian company to be granted marketing authorization for an antimalarial drug by the 27 EU Member States from the EMA.

Eurartesim, a fixed-dose combination of two antimalarials, dihydroartemisinin and piperaquine (DHA-PQP), is generally well-tolerated and is administered once a day for 3 days instead of twice a day, making the drug more patient friendly. In addition, clinical trials have shown that compared to other approved ACTs, Eurartesimprovides better and longerprotection from new malaria infections. This is good news for children in high transmission areas who often succumb to another life-threatening malaria episode after they have recovered from the first1.

The EMA’s authorization is based on the results of a series of large-scale clinical trials that assessed Eurartesim’s safety and efficacy in comparison to artemether-lumefantrine or artesunate + mefloquine. The studies tested this ACT in more than 2,700 patients in Africa (Burkina Faso, Zambia, Kenya, Mozambique and Uganda) and in Asia (Thailand, India and Laos), in around 1,036 African children aged 6 months to 10 years, all affected by uncomplicated P. falciparum malaria.

“Clinical studies carried out on patients treated with Eurartesim have confirmed high cure rates, above 95% - says Marco Corsi, Sigma-Tau’s Medical Director.Moreover, compared to comparator drugs, Eurartesimhas shown a secondary protective effect - an almost 50% reduction in the number of new infections in the 2 months following treatment. In highly endemic countries, where treated patients often become newly infected, this secondary protective effect might have a positive outcome on public health. The marketing authorization for Europe will allow us not only to provide a highly effective treatment to vulnerable populations of endemic countries, where malaria has a devastating impact on health and socio-economic systems, but also to European citizens.”

Developed to high internationally recognized standards, Eurartesimmeets the therapeutic guidelines outlined by the World Health Organization (WHO) which, on the basis of clinical evidence, recommends the combination of two active ingredients in the same tablet: an artemisinin derivative with a high antimalarial efficacy (dihydroartemisinin) and a second antimalarial drug (piperaquine),  which helps protect the artemisinin component from the risk of resistance.

“The approval of Eurartesimby the EMA comes at a critical time in the fight against malaria - says David Reddy, CEO, MMV. This high quality treatment is a much-awaited addition to the malaria arsenal and will be welcomed by health care professionals in a number of malaria-endemic countries. Eurartesimis the product of a close collaboration between MMV and Sigma-Tau. The partnership between Sigma-Tau and MMV will continue as we focus on the development of a paediatric formulation of the treatment targeted at children under 5 years of age.”

 


1. Bassat Q, Mulenga M, Tinto H, Piola P, Borrmann S, et al. (2009) Dihydroartemisinin-Piperaquine and Artemether-Lumefantrine for Treating Uncomplicated Malaria in African Children: A Randomised, Non-Inferiority Trial. PLoS ONE 4(11): e7871. doi:10.1371/journal.pone.0007871