Eurartesim® is a fixed-dose combination of dihydroartemisinin-piperaquine (DHA-PQP), developed by Alfasigma S.p.A. in partnership with MMV, for the treatment of uncomplicated P. falciparum malaria. It is administered once a day over 3 days. Studies have shown that Eurartesim’s long half-life affords patients a useful period of protection from new malaria infections.1,2
In October 2011, the EMA granted marketing authorization for Eurartesim. In October 2015, Eurartesim was prequalified by WHO and, in June 2017, DHA-PQP was added to the World Health Organization’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc) after a successful application to the EML by Alfasigma.
In 2015, Alfasigma entered into an exclusive licensing agreement with Pierre Fabre to expand its ability to support country registration requirements and national adoption of Eurartesim in 32 African countries. MMV, Alfasigma and Pierre Fabre are working closely with normative bodies, financing entities, and national/international implementing partners to ensure appropriate product introduction and use of Eurartesim in malaria-endemic countries.
Alfasigma will submit a regulatory dossier to the EMA for a new dispersible formulation of Eurartesim designed specifically to address the treatment needs of children.