Pyronaridine-artesunate demonstrates high real-life safety, tolerability and effectiveness in the treatment of uncomplicated malaria in large multi-country study in Africa
MMV and Shin Poong Pharmaceutical Co. Ltd., announce the publication of the largest real life study of Pyramax® (pyronaridine-artesunate) for the treatment of uncomplicated malaria to date, with over 8,500 malaria episodes across five African countries.1 The study, conducted in partnership with the Central Africa Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM)2, the University of Agboville, Cote d’Ivoire and the University of Tübingen, reported high effectiveness (D28 PCR-adjusted cure rate of 98.6%) and safety and tolerability under conditions similar to everyday clinical practice.
Completion of this 2-year study fulfils Shin Poong and MMV’s post-approval commitment to the European Medicines Agency (EMA), following a positive scientific opinion for the use of Pyramax under the Article 58 procedure for both tablets and the child-friendly granule for suspension presentation. The EMA requested this large study to provide supplementary assurance regarding the real-life safety—in particular, liver safety—and tolerability of Pyramax in populations not assessed in the previous studies, given that it would be used outside of the EU and in malaria-endemic countries where pharmacovigilance systems may not be fully developed.
The study demonstrated high real-life safety, tolerability and effectiveness even in patients who had pre-existing hepatic impairment. The study population included patients with acute hepatitis, in addition to those with HIV, malnourished patients, children under 1 year of age and women who were unknowingly pregnant; overall, this was a much broader population than that of the previous phase 3 programme and WANECAM study.
“Through the CANTAM study, we have demonstrated the real-world utility of Pyramax while also providing access to an approved quality-assured artemisinin-combination therapy, to malaria patients in some of the most remote areas in Africa,” said Prof. Francine Ntoumi, CANTAM Coordinator. “The collaboration with MMV and Shin Poong Pharmaceutical Co. Ltd. has strengthened the Central African clinical research network by supporting our need to conduct a multicentric clinical trial. This major study provided the opportunity to implement all the skills that have been acquired by staff since the creation of CANTAM in 2009. This successful endeavour with MMV and Shin Poong Pharmaceutical Co. Ltd. allows CANTAM to stand as a competitive group for conducting relevant clinical trials in the region.”
“Pyramax has been a joint development with MMV since 2001, and we are very proud that its utility, efficacy and safety in clinical practice have been confirmed in this huge real-life study, proving that Pyramax is an optimal ACT, even in challenging real-life settings. The study results reinforce its use as a powerful and well-tolerated first line ACT. We will continue to produce this high-quality product to meet the demand to support malaria elimination and eradication efforts,” said Mr Won June Chang, CEO of Shin Poong Pharmaceutical Co. Ltd.
“Malaria continues to kill more than 400,000 lives a year, mostly African children under 5 years old, often in remote rural settings,” said George Jagoe, MMV’s EVP of Access and Product Management. “These positive results from the CANTAM study confirm that Pyramax may be used widely in community settings to help save the lives of adults and children with malaria. MMV is committed to working with Shin Poong and in-country partners to make Pyramax as accessible as possible.”
→Learn more about Pyramax from Dr Eric's story.
1. Gabon: Albert Schweitzer Hospital (CERMEL), Lambaréné, Côte d’Ivoire: Health Center of Azaguié & Health Center of Agboville, Cameroon: Biotechnology Center, University of Yaoundé & Mfou District Hospital, Congo: Congo foundation for the Medical Research, Brazzaville, Makélélé Hospital, Health Center of Madibou, DR of Congo: Faculty of Medicine, University of Kinshasa, Mont-Amba Hospital, Kinshasa, Evangelic Medical Institute of Kimpesé
2. For more information about CANTAM, please visit: https://www.cantam.org/index.php/cantam-about-us