Dihydroartemisinin-piperaquine submitted to EMEA for regulatory approval

Landmark event and the culmination of several years’ productive collaboration between sigma-tau and Medicines for Malaria Venture

06 Jul 2009

Dihydroartemisinin-piperaquine, one of MMV’s late-stage projects, has been submitted to the EMEA on 2 July 2009 for regulatory approval. DHA-Piperaquine was developed over four years in partnership with sigma-tau Industrie Farmaceutiche Riunite in Rome, Italy. DHA-Piperaquine is highly effective against P. falciparum malaria in adults and children, has a simple dosing regimen (only 3 administrations over 3 days) and has been shown to offer greater protection against new infections than other ACTs, for at least 2 months after treatment. The regulatory dossier comprises data from large clinical trials that involved over 2,700 patients in Africa and Asia of whom 1,600 were children under 5. The studies were designed to compare the safety and efficacy of the combination of DHA-Piperaquine to the ACTs artemether/lumefantrine (in Africa) and artesunate+mefloquine (in Asia).

This new ACT is the first product of a collaboration between sigma-tau and Medicines for Malaria Venture (MMV). Developed to high international standards, DHA-Piperaquine meets WHO clinical treatment recommendations, as it combines two active antimalarial ingredients in a single tablet: the highly potent artemisinin-derivative (dihydroartemisinin) with a second antimalarial (piperaquine) which protects the first one against the emergence of resistance.

“The submission of DHA-Piperaquine to the EMEA is a landmark event and the culmination of several years’ productive collaboration between sigma-tau and Medicines for Malaria Venture," said Dr Chris Hentschel, President and CEO of Medicines for Malaria Venture. "Head-to-head studies carried out to internationally approved standards have shown that this ACT is at least as well tolerated and efficacious as two other well-known ACTs. Its addition to the therapeutic arsenal will give more choice to health policy makers and caregivers in malaria-endemic countries to choose the right medicine for their patients.”