WHO formally recommends inclusion of artesunate-pyronaridine in its guidelines for the treatment of malaria

SWITZERLAND —The World Health Organization’s (WHO) Guideline Development Committee has recommended the formal inclusion of Pyramax in the guidelines with a “strong” recommendation for treating malaria.

The recommendation follows a review of Pyramax, which included one of the largest clinical studies to evaluate its real-world efficacy and safety.

Pyramax is a fixed-dose artemisinin-based combination therapy (ACT) and the only one to be specifically indicated for the blood-stage treatment of the two dominant species of malaria parasite: P. falciparum and P. vivax.

The medicine is also available in a child-friendly granule formulation to ensure palatability and therefore correct dosage in this vulnerable population.

Both Pyramax tablets and Pyramax granules received European Medicines Agency (EMA) positive scientific opinions from the Committee for Medicinal Products for Human Use (CHMP) through Article 58, based on a robust development program. 

To date, over 2.9 million malaria patients have been treated with the medicine, including children under the age of 1.

Both formulations are currently registered for the treatment of uncomplicated malaria in 29 countries in Africa and Asia. 

If left untreated, a bout of uncomplicated malaria can quickly evolve into severe malaria, which may have life-threatening consequences.

The World Health Organization (WHO) recommends that malaria be treated with combinations of drugs called artemisinin-based combination therapies (ACTs).

Pyramax was included in the WHO’s list of pre-qualified medicines in 2012, and in the WHO’s Essential Medicines Lists for both adults and children in 2017.

Pyramax has subsequently undergone a positive review by the WHO’s Advisory Committee on the Safety of Medicinal Products in 2019, which included a review of interim data from the CANTAM study.

Pyronaridine-artesunate is a new ACT. New ACTs are needed to treat malaria that has become resistant to currently available ACTs and to help prevent malaria from becoming more resistant to treatment.

According to the latest World Malaria Report, there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020. This represents about 14 million more cases in 2020 compared to 2019, and 69,000 more deaths.

Approximately two-thirds of these additional deaths (47,000) were linked to disruptions in the provision of malaria prevention, diagnosis, and treatment caused by the COVID-19 pandemic.

Moreover, in the past 2 years, the emergence of parasite mutations associated with drug resistance in Africa has been confirmed, with delayed parasite clearance; hence delayed cure already seen in Rwanda, Uganda, and the Horn of Africa.

The official inclusion of Pyramax into WHO’s Guidelines for malaria is a crucial step allowing malaria-endemic countries to choose Pyramax as a first-line ACT with confidence.