Eurartesim® (dihydroartemisinin-piperaquine) receives WHO prequalification

WHO’s positive assessment will help bolster broader use of this life-saving medicine

26 Oct 2015

This month, the WHO Prequalification Team has added Eurartesim® (dihydroartemisinin-piperaquine, DHA-PQP) to its list of prequalified medicines. MMV has been working closely with partner Sigma-Tau to achieve this approval.

Via the prequalification process, the WHO assesses and approves the quality, safety and efficacy of medicinal products. The objective is to provide international procurement agencies with a wide selection of quality-assured medicines for purchase. Eurartesim is now included in that selection.

DHA-PQP is one of the artemisinin-based combination therapies (ACTs) recommended by WHO for the treatment of uncomplicated malaria. It has been adopted as first-line treatment in several Southeast Asian countries and is increasingly considered for second-line and in some cases first-line treatment in African countries. Eurartesim is also under evaluation in various mass drug administration trials and is being tested as a tool for intermittent preventive treatment during pregnancy.

Eurartesim was approved by the European Medicines Agency in 2011 for the treatment of uncomplicated malaria. 

“DHA-PQP is a medicine that has generated growing interest throughout the malaria community since it was first recommended by the WHO in 2010,” says George Jagoe, MMV’s EVP for Access. “Eurartesim is the only version of DHA-PQP with stringent regulatory approval and so now, WHO prequalification represents the second critical milestone on the path to make this highly efficacious medicine available to as many malaria patients as possible.”

“Since 2011, Sigma-Tau has supplied Eurartesim at an affordable price because we believe it is our moral obligation to support the universal right to health.” Dr Gianemilio Stern, Sigma-Tau’s Malaria Franchise Project Leader, explained. “Our objective is to ensure that therapies recommended by the WHO actually reach those who need them the most and contribute to a future without malaria for the countries heavily impacted by malaria.”