Eurartesim® (dihydroartemisinin-piperaquine) registered in first African country

Ghana approves new MMV co-developed antimalarial

07 Mar 2013

Ghana has become the first African country to approve Eurartesim®, a high-quality, fixed-dose combination of dihydroartemisinin-piperaquine (DHA-PQP). DHA-PQP is one of the artemisinin combination therapies (ACTs) recommended by WHO’s Standard Treatment Guidelines for the treatment of uncomplicated P. falciparum malaria. Developed by Sigma-Tau in partnership with MMV, Eurartesim was approved by the European Medicines Agency in 2011.

This is a critical milestone for malaria treatment in Africa. Several African countries have used non-quality-assured versions of DHA-PQP in the past, while others have wanted to include the medicine in their Global Fund grants. With this landmark registration in Ghana, a quality-assured version of DHA-PQP will now be within the reach of African patients.

In addition, this registration will enable Eurartesim to be used within the INESS1 Phase IV programme that gathers data on the safety and effectiveness of new ACTs and shares the information with other malaria-endemic countries. MMV is working closely with Sigma-Tau to register the drug for use in a number of other malaria-endemic countries including all of those involved in the INESS programme (Ghana, Burkina Faso, Mozambique and Tanzania).

Ghana has already adopted DHA-PQP into its malaria standard treatment guidelines with other first-line treatments. With the registration of Eurartesim complete, it can now procure the drug through international funding agencies and provide a greater choice of high-quality medicines to patients.  

A wider range of therapies to treat malaria enables disease-endemic countries to adapt control strategies to their specific needs. The use of multiple first-line therapies against malaria potentially yields a better clinical outcome than using a single therapy, particularly when drug resistance or treatment failures emerge.2

“We are delighted with the news of Eurartesim’s registration in Ghana and look forward to the additional registrations so that it can be used in all INESS countries as quickly as possible,” said Prof. Fred Binka, Principal Investigator of the INESS Team. “The data generated by INESS will give us unique insights into the safety/effectiveness profile of Eurartesim and help show how it can be best used in the management of malaria.”

1. INESS: INDEPTH Effectiveness and Safety Studies of Antimalarials in Africa

2. Boni MF, Smith DL, Laxminarayan R. Benefits of using multiple first-line therapies against malaria. Proc Natl Acad Sci U S A. 105(37):14216-21 (2008).