WHO issues information note about Pyramax® (artesunate-pyronaridine) for uncomplicated malaria

Countries can procure the medicine and include it in their national treatment guidelines

09 Oct 2019

MMV welcomes the release of WHO’s information note on the use of artesunate-pyronaridine for the treatment of uncomplicated malaria stating that "artesunate-pyronaridine can be considered a safe and efficacious artemisinin-based combination therapy (ACT) for the treatment of uncomplicated malaria in adults and children weighing 5 kg and over in all malaria-endemic areas.”

The aim of the note is to clarify any perceived discrepancy between the inclusion of the medicine in the WHO list of prequalified medicines for malaria and Model List of Essential Medicines, and the recommendations in the 2015 WHO Guidelines for the Treatment of Malaria. It is expected that these guidelines will be updated in due course.

Artesunate-pyronaridine (Pyramax®), is a fixed dose ACT co-developed by MMV and Shin Poong Pharmaceutical co. Ltd. and is the only ACT to be specifically indicated for the blood-stage treatment of the two dominant strains of malaria: P. falciparum and P. vivax. The medicine is also available in a child-friendly granule formulation to enhance palatability in this vulnerable population.

In 2012 Pyramax received a positive opinion from the European Medicines Agency and was added to the WHO list of prequalified medicinal products. In 2015 it was granted a revised label and Pyramax granules received a positive opinion from the European Medicines Agency. In 2016 Pyramax granules was added to the WHO List of Prequalified Medicinal Products and in 2017, to the WHO Model Lists of Essential Medicines. Since 2014, the product has been registered with national regulatory authorities in over 25 malaria endemic countries.

“Two recent reports, one by the WHO Strategic Advisory Group on Malaria Eradication (SAGMe) and the other by the Lancet Commission on Malaria Eradication, both highlight the importance of continued innovation and the need for new tools in the fight against malaria,” said Dr David Reddy, CEO of MMV. “Given mounting concerns of malaria drug resistance, there is a need for a wider variety of quality-assured antimalarial medicines for use in malaria-endemic countries. Pyramax represents an important addition to the ACT family. MMV welcomes the positive outcome of WHO’s assessment process, which will facilitate increased access by patients to this new treatment option.”