MMV has long recognized that developing better medicines for children is vital, as this most vulnerable patient population is at the greatest risk of dying from malaria.
Coartem® Dispersible (artemether lumefantrine), Pyramax® granules (pyronaridine-artesunate), and Eurartesim® dispersible (dihydroartemisinin-piperaquine) represent real progress in the treatment of the most vulnerable. To support their optimal use in the real world, MMV has been working with partners to generate and disseminate post-approval evidence on their safety and efficacy in the real world.
Dr Issaka Sagara was one of the investigators for a large phase IIIb/IV multicentre clinical study designed to evaluate the safety and efficacy of ACTs over a 2-year follow-up period led by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM). He talks us through the study results (published at the end of 2015),1 how WANECAM supported the approval of the new child-friendly antimalarial, Pyramax granules, and his experience of working with MMV.
1. What did the WANECAM study look at, particularly for Pyramax?
One of the objectives of the WANECAM study was to collect the data necessary to enable repeat use of Pyramax in malaria-endemic countries. In this 2-year follow-up study, patients from Mali, Burkina Faso and Guinea were retreated with either Pyramax or Eurartesim each time they had a malaria episode, and the results were compared with the standard treatments available in the region (Coartem and ASAQ Winthrop®), both of which are already approved for repeated use.
2. What did the WANECAM study tell us about Pyramax?
Importantly, our analysis revealed that the efficacy and safety of Pyramax after multiple re-treatments remained consistent with a single administration. These findings, based on an interim analysis of the data published online in the Lancet Infectious Diseases journal in October 2015,1 informed the EMA’s decision to issue an updated positive scientific opinion for Pyramax tablets, supporting repeated use. That revision also removed requirements for liver-function monitoring and geographic restrictions on its use.
At the same time, the results helped support the EMA’s decision to issue a positive scientific opinion for Pyramax granules. In the WANECAM study, we noticed improved adherence to treatment with Pyramax granules – the drug is taste masked, so easier to administer to children and only needs to be dosed once-daily. We hope this will facilitate wider use of Pyramax as a well-tolerated, alternative ACT for children, especially in those malaria-endemic countries where paediatric antimalarial treatments are limited. In addition, broadening treatment options might delay or even prevent resistance to the currently available antimalarials in the region.
3. What was it like to work with MMV on the WANECAM study? What are the next steps?
Speaking on behalf of all three countries involved in the WANECAM study, we would like to thank MMV for all its support and guidance. Our resources on the ground are relatively limited, so we benefited enormously from MMV’s technical expertise and advice. Malaria is the number one public health concern here in West Africa. Based on the success of this study and the approval of Pyramax for multiplecourse administration, we now have a powerful new weapon in the fight against malaria.
The next step is to partner with national malaria control and elimination programmes in endemic countries to implement pilot schemes aimed at reducing the disease burden and slowing development of resistance to existing treatments. In parallel, new studies, such as a phase IIIb/IV to be carried out by the Central African Network on TB, HIV/AIDS and Malaria (CANTAM) in five African countries, will help us to continue monitoring the safety and the impact of Pyramax in real-world settings.
- Sagara I et al. “Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial.” Lancet Infect Dis. 16(2):189-98 (2016).