European regulators grant Pyramax® a revised label
Pyramax® (pyronaridine-artesunate), a once-daily, 3-day artemisinin combination therapy (ACT) for uncomplicated malaria, has received a positive scientific opinion under article 581 from the European Medicine’s Agency (EMA) for a new label allowing it to be used to treat malaria without geographic restrictions or limitations on its repeat dosing.
In 2012, Pyramax tablets for adults and children ≥20 kg, developed by Shin Poong Pharmaceutical Co. Ltd. and MMV became the first ACT to receive a positive scientific opinion under the EMA’s article 58 procedure, for the treatment of uncomplicated malaria caused by the two main species of malaria parasite (P. falciparum and P. vivax). Due to limited data on the repeated use of the medicine and potential implications on hepatic safety, Pyramax was initially only approved for the treatment of a single malaria episode in areas of low transmission with evidence of artemisinin resistance.
To collect the data necessary to enable broader use of Pyramax in endemic countries, MMV joined forces with the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM). Led by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali, with funding from European & Developing Countries Clinical Trials Partnership (EDCTP) and MMV, the WANECAM phase IIIb/IV study was designed to evaluate the safety and effectiveness of ACTs. Over a 2-year follow-up period, patients were treated with the same antimalarial each time they had a malaria episode. Pyramax and Eurartesim® (dihydroartemisinin-piperaquine) were compared with standard treatment in the region (artemether-lumefantrine and artesunate-amodiaquine).
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 revised label for Pyramax and the positive scientific opinion for a new child-friendly formulation, Pyramax® Granules.
This enhanced label will support further endemic-country registrations,2 facilitating Pyramax’s use as an alternative ACT for patients in sub-Saharan Africa. Meanwhile, a planned Phase IV pharmacovigilance study will generate further data about Pyramax tablets and Pyramax Granules in real-life settings.
“The label variation is excellent news,” said David Reddy, MMV’s CEO. “We are proud to have worked in collaboration with Shin Poong, Professor Djimde and his fellow investigators in the WANECAM network. The recent publication of the effectiveness and safety data from the WANECAM study in Lancet Infectious Diseases coupled with the EMA positive opinion underscore the importance and quality of the data generated by this collaboration. Increasing the repertoire of well studied and quality antimalarial medicines is crucial as the global health community intensifies malaria control and elimination efforts.”
- 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.
- Pyramax tablets are currently approved in Myanmar, Vietnam, Cambodia, Guinea, Burkina Faso, Cote d’Ivoire, Chad, Gabon, Mozambique, Central African Republic and Congo