Strong Recommendation for Pyronaridine-Artesunate in Revised World Health Organization (WHO) Malaria Treatment Guidelines

Inclusion in the latest version of the WHO Guidelines for malaria is a key step towards broader use of the medicine.

MMV (http://www.MMV.org) and Shin Poong Pharm. Co., Ltd. welcome the formal inclusion of Pyramax^® (pyronaridine-artesunate) in the World Health Organization’s (WHO) Guidelines for Malaria (http://bit.ly/3EZSJep) following an extensive review process.

The WHO’s Guidelines for the Treatment of Malaria are the standard reference which guide country-level policies for managing malaria. New medicines are only recommended for inclusion following a robust and in-depth evaluation of evidence using the GRADE (http://bit.ly/3XuGnSy) framework, which provides a systematic approach for making clinical practice recommendations. Following this review – which included one of the largest clinical studies to evaluate real-world efficacy and safety of any antimalarial – the Guideline Development Committee recommended the formal inclusion of Pyramax in the guidelines with a “STRONG” recommendation – the highest level of confidence.

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 programme.  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.  

Following the positive scientific opinions for use, a large Cohort Event Monitoring study was implemented in 5 African countries in under the supervision of the CANTAM Network to evaluate the safety and effectiveness of Pyramax under conditions similar to everyday clinical practice. This study, which reported high effectiveness (D28 PCR-adjusted cure rate of 98.6%), included over 8,500 acute malaria episodes in 7,154 patients, and has recently been published in PLoS Medicine.

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.

Following this review in October 2019 and pending the next revision of their Guidelines for Malaria, the WHO published an Information Note supporting the use of Pyramax at country level, stating that “artesunate-pyronaridine can be considered a safe and efficacious ACT for the treatment of uncomplicated malaria in adults and children weighing 5 kg and over in all malaria-endemic areas….countries can consider including this medicine in their national treatment guidelines for the treatment of malaria”.

“The addition of Pyramax to the WHO Guidelines for malaria is an achievement that we are proud to have reached with our long-standing partner Shin Poong Pharm. Co., Ltd.,” said Dr David Reddy, MMV’s CEO. “We ventured into the Pyramax project to help save the lives of adults and children with malaria. Therefore, we will continue to work with Shin Poong to register both the tablets and granules of Pyramax in more malaria-endemic countries, facilitating equitable access to this important new addition to the malaria treatment toolkit.”

"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. The managerial decision to commence the Pyramax project was based on Shin Poong’s core values and company policies, which have guided us for over half a century. We will continue to produce qualified products to supply potent, reliable, simple treatment to patients", said Shin Poong Pharm. Co., Ltd.

November 25, 2022