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Pyramax® approved as antimalarial for treatment of multiple episodes of malaria

20 November 2015

The European Medicines Agency (EMA) published today a positive scientific opinion on Pyramax®, a once-daily, 3-day treatment for uncomplicated malaria. The new label allows it to be used for treating multiple episodes of malaria in the same person after registration in malaria-endemic countries. Even more excitingly, the child-friendly fixed-dose ACT Pyramax® Granules is the first paediatric antimalarial to be approved by the EMA.

“We congratulate the study team and the MMV-Shin Poong partnership with this important result. Multiple episodes of malaria in the same person are a common occurrence in high-endemic areas, especially in Africa. This study provides valuable safety data to address this challenge. Moreover, a child-friendly formulation is made available for use in this high-risk patient population.”

Dr Michael Makanga, Director of South-South Cooperation and Head of Africa Office

The West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) phase IIIb/IV led by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali, evaluated the safety and effectiveness of antimalarials over a 2 year period. Pyramax® and Eurartesim® (dihydroartemisinin-piperaquine) were compared with ACTs used for standard treatment in the region (artemether-lumefantrine and artesunate-amodiaquine). Patients were treated with the same antimalarial each time they had a malaria episode.

A sub-study analysis of the patients treated with Pyramax® revealed that the medicine was as well tolerated and efficacious on retreatment as on first administration. These findings recently published in The Lancet Infectious Diseases were used to support the label variation for Pyramax® and a positive scientific opinion of a new child friendly formulation of the ACT, Pyramax® Granules.

In its press release MMV states: “In parallel with the introduction of Pyramax Granules in endemic countries, MMV and Shin Poong will work with partners to conduct a Phase IV pharmacovigilance study to generate further data about Pyramax tablets and Pyramax Granules in real-life settings”.

Pyramax®

Pyramax® tablets for adults and children ≥20 kg and Pyramax® Granules for children and infants between 5 and 20 kg were developed by Shin Poong Pharmaceutical and Medicines for Malaria Venture (MMV). In 2012, Pyramax tablets  became the first artemisinin-based combination therapy (ACT) for the treatment of the two main species of malaria to receive a positive scientific opinion under the EMA’s article 58 process (evaluation of medicinal products intended exclusively for markets outside the European Community). Owing to limited data on the repeated use of the medicine, at the time it could only be indicated for the treatment of a single malaria episode in areas of low transmission with evidence of artemisinin resistance.

Funding

The WANECAM study with a total budget value of almost €12.5M was mainly funded by MMV and EDCTP. Other funders are the UK Medical Research Council, Swedish International Development Cooperation Agency, German Ministry for Education and Research, University Claude Bernard (Lyon, France), Malaria Research and Training Centre (Bamako, Mali), Centre National de Recherche et de Formation sur le Paludisme (Burkina Faso), Institut de Recherche en Sciences de la Santé (Bobo-Dioulasso, Burkina Faso), and Centre National de Formation et de Recherche en Santé Rurale (Republic of Guinea).