Eine neue Therapieroute bei unkomplizierter Malaria tropica: eurartesim®
|eurartesim® - data and facts|
|Dr. med. Marco Corsi|
|The clinical development of
eurartesim® (dihydroartemisinin/piperaquine) started in 2004,
through a partnership between Medicines for Malaria Venture (Switzerland),
University of Oxford (UK) and sigma-tau S.p.A. (Italy). Eight clinical trials
have been carried out, covering pharmacokinetics (PKs), food interaction,
Thorough QTc and Phase III.
The latter were two pivotal, randomized, open-label, multicenter trials in patients with uncomplicated P. falciparum malaria. One trial was carried out in Africa (five countries) in about 1.500 children <5 years, having artemether/lumefantrine (AL) as comparator, and the other was carried out in three Asian countries in about 1.200 patients (children and adults) where artesunate/mefloquine (AS/MQ) was used as comparator. Both trials demonstrated that eurartesim® is not inferior to AL and AS/MQ in terms of PCR-corrected cure rates, while is superior in terms of rate of new infections during the follow up periods, respectively 42 and 63 days.
The eurartesim® formulations were generally well tolerated. The registration dossier has been filed at EMA for a centralized registration in July 2009 and the approval has been granted in October 2011.