Eurartesim® reaches Cambodia

First shipment of medicine delivered

19 Jul 2012

More than 160,000 packages of Eurartesim (dihydroartemisinin-piperaquine or DHA-PQP) have been delivered to Cambodia, making it the first shipment of Eurartesim to a malaria-endemic country. This significant achievement is the result of excellent collaboration between the Ministry of Health Cambodia (National Center for Malaria Control, Parasitology and Entomology – CNM; and the Department of Drugs and Food – DDF), PSI (Cambodia and Kenya), the Global Fund, WHO (Geneva and Cambodia), Sigma-Tau and MMV.

Cambodia, situated at the epicenter of emerging resistance to many existing antimalarials, is the first malaria-endemic country to place an order for this newly approved treatment. Cambodia adopted DHA-PQP as first-line treatment for malaria and was awaiting approval by a stringent regulatory agency to allow procurement of Eurartesim using international donor funds. 

Eurartesim was developed by Sigma-Tau in partnership with MMV for the treatment of uncomplicated P. falciparum malaria. It is administered once a day for 3 days, making it easier for patients to comply with the dosing. In addition, studies have shown that Eurartesim has a greater capacity than other ACTs to protect patients from new malaria infections.1, 2

In October 2011, Eurartesim became the first antimalarial to be approved by the European Medicines Agency. Sigma-Tau has recently submitted the Eurartesim dossier for WHO prequalification and is in the process of submitting it for national registrations in four INESS countries: Tanzania, Burkina Faso, Mozambique and Ghana, where Phase IV studies are planned to monitor the effectiveness and safety of new, approved antimalarial drugs in “real-life” settings.

The Sigma-Tau and MMV team will continue to work together to ensure the medicine is available to patients, physicians and health workers in malaria-endemic countries.

The partnership is also developing a paediatric formulation of Eurartesim for the most vulnerable group – children between the age of 6 months and 5 years.

 


 

1. Valecha Net al. An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia. PLoS One. 5(7):e11880 (2010).

2. Bassat Q, Mulenga M, Tinto H, Piola P, Borrmann S, et al. (2009) Dihydroartemisinin-Piperaquine and Artemether-Lumefantrine for Treating Uncomplicated Malaria in African Children: A Randomised, Non-Inferiority Trial. PLoS ONE 4(11): e7871. doi:10.1371/journal.pone.0007871

 

Safety Statement on Eurartesim

Dihydroartemisinin-piperaquine is generally well tolerated. Its safety has been evaluated in two open-label studies in which it was used to treat 1,239 paediatric patients aged up to 18 years and 566 adults aged over 18 years.

Side-effects were found to be mild and generally not serious. In adults, the most common side-effects (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), headache, QTc prolongation (an alteration of the electrical activity of the heart, which can cause a life-threatening abnormality of heart rhythm), tachycardia (rapid heartbeat), asthenia (weakness) and pyrexia (fever). In children, the most common side effects (seen in more than 1 patient in 10) were influenza (flu), cough and pyrexia.

Dihydroartemisinin-piperaquine must not be used in patients who are hypersensitive (allergic) to the active substances or any of the other ingredients. It must not be used in patients with severe malaria (which may be life threatening). It must not be used in patients who have or are at risk of QTc interval prolongation or cardiac arrhythmias (unstable heartbeat) due to heart conditions or taking medicines that can affect heart rhythm. Due to this risk of QTc prolongation it is important that Eurartesim is taken without food and at least three hours from any meal. Dihydroartemisinin-piperaquine should also not be used during pregnancy if an effective alternative medicine is available.