Pyramax® granules (pyronaridine-artesunate) for children added to WHO list of prequalified medicines

Technical briefing addresses the implementation strategy to provide rapid access to this drug in malaria-endemic countries

20 Apr 2016

Pyramax® granules (pyronaridine-artesunate) for the treatment of uncomplicated malaria in children from 5-20kg was added to the World Health Organization’s (WHO) list of prequalified medicines in March 2016. This follows the European Medicines Agency’s (EMA) decision to grant the medicine a positive scientific opinion through its Article 58 procedure in November 2015 – making Pyramax granules the first fixed-dose artemisinin combination therapy (ACT) developed specifically for children to be granted this opinion through article 58.

Simultaneous with its review of Pyramax granules, the EMA also authorized significantly expanded use of Pyramax tablets for patients >20kg. While this medicine was first granted a positive scientific opinion by the EMA in 2012, the new label expands the possibility of Pyramax’s deployment in all malaria-endemic countries, allowing for repeated treatments.

Pyramax is the result of a product development partnership between Medicines for Malaria Venture (MMV), and Shin Poong Pharmaceutical Co. Ltd., Republic of Korea. Beginning in 2002, this drug development programme led to the testing of Pyramax in over 3,500 malaria patients in clinical studies in 18 countries in Africa and Asia, in which the medicine has shown high efficacy – similar to existing WHO-recommended ACTs.  

Following the EMA’s initial positive scientific opinion in 2012, Pyramax was included in an extensive Phase IIIb /IV trial conducted by the West African Network for Antimalarial Drugs (WANECAM) from 2011–2016. Publication of a sub-analysis of the findings in the Lancet Infectious Diseases in October 20151 reconfirmed the safety and efficacy of Pyramax, even when re-dosed up to 8 times in a single patient over a 2-year follow-up period.

A technical briefing is being held today to address the clinical evidence that forms the basis of this positive scientific opinion, the implementation strategy to provide rapid access to this drug in malaria-endemic countries, and the vital role of Pyramax in malaria control, elimination and eradication.

1. Sagara I et al. “Safety and effi cacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial.” Lancet Infect Dis 16: 189–98 (2016).