Monday, 5 December 2011

MALARIA: EurartesimR (dihydroartemisinin-piperaquine)

 November 30, 2011

 ACT to combat malaria receives marketing authorization from EMA
EurartesimR (dihydroartemisinin-piperaquine)
ACT to combat malaria receives marketing authorization from EMA
. A fixed-dose combination therapy to combat malaria, EurartesimR, (dihydroartemisinin-piperaquine) the product of Italian research conducted  by Sigma-Tau and MMV, approved by the European Medicines Agency (EMA)
Therapy with a simple dosage regimen, up to 3 tablets once a day for 3 days. Studies have demonstrated high cure rates, above 95%, and a significant reduction of re-infection rates compared to leading
antimalarial treatments
Every year almost 250 million people all over the world are affected by malaria. The disease takes the lives of over 780,000 people, mainly in sub-Saharan Africa, 85% of whom are children under 5
Geneva, 30 November 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, EurartesimR (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, Eurartesim provides better and longer protection 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, Eurartesim has 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, Eurartesim meets 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 Eurartesim by 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. Eurartesim is 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."

Jaya Banerji: e-mail:

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