New study details safety and efficacy of re-treatment with Pyramax®
Interim data from a clinical trial led by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) published online today inThe Lancet Infectious Diseases supports the safety and efficacy of the artemisinin-based combination therapy (ACT) Pyramax®(pyronaridine-artesunate) when used for the re-treatment of adults and children over 5 kgs with malaria.
Pyramax, developed by Shin Poong Pharmaceutical and Medicines for Malaria Venture (MMV), is a once-daily, 3-day treatment for uncomplicated malaria. In 2012, it became the first ACT to receive a positive opinion under the European Medicines Agency’s Article 58 process,1 and is currently indicated for treatment of a single malaria episode in areas of low transmission with evidence of artemisinin resistance.
The WANECAM sub-study data are now being used to support an application for a label change to allow for re-treatment with the medicine and support its use in all malaria-endemic regions including sub-Saharan Africa, where the global burden of malaria weighs most heavily.
“This is an important paper,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. “It shows that the new medicine is consistently well tolerated and efficacious when given many times over a 2-year period. This is very relevant in parts of the world where children risk being bitten by an infectious mosquito every night, and some get malaria four or five times each year.”
The WANECAM trial, a large, phase IIIb/IV multicentre clinical study, led by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali, was designed to evaluate the safety and effectiveness of ACTs. Over a 2-year period, patients were randomized and treated with the same antimalarial each time they had a malaria episode. The study compares two ACTs which have recently been successfully reviewed by the European Medicines Agency (Pyramax and Eurartesim®, dihydroartemisinin-piperaquine) with ACTs that are standard treatment in the region (artemether-lumefantrine and artesunate-amodiaquine). The sub-study analysis was planned to provide data on the re-treatment of Pyramax to support its wider use.
“This is a major step forward in the fight against malaria in sub-Saharan Africa,” said Prof. Abdoulaye Djimde. “The demonstration thatPyramax is well-tolerated when used to treat multiple episodes of malaria will help to bring this new ACT to countries where the current choice of efficacious antimalarial drugs is very limited.”
1. Article 58 of Regulation (EC) No 726/2004 was created in 2004. Technically, it establishes a mechanism for the European Medicines Agency to give a scientific opinion, in cooperation with the World Health Organization (WHO), for the evaluation of medicinal products intended exclusively for markets outside the (European) Community.