If left untreated, a bout of uncomplicated malaria can quickly evolve into severe malaria, which may have life-threatening consequences. Timely access to the appropriate treatment for uncomplicated malaria is key to avoiding this scenario.
Pyramax is a once-daily, 3-day therapy indicated for the treatment of acute uncomplicated P. falciparum and P. vivax malaria in adults and children over 20 kg (Pyramax tablets) and in children and infants between 5 and 20 kg (Pyramax granules).
A high-quality artemisinin-based combination therapy (ACT)
Pyramax is the only ACT to be granted a positive scientific opinion under the European Medicines Agency’s (EMA) Article 58 procedure, and is also the only ACT to be registered by a stringent regulatory authority for the blood-stage treatment of both of the two main strains of malaria: P. falciparum and P. vivax.
Pyramax was added to the WHO’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc) in 2017. Its procurement and use at a country level is further supported by a WHO Information Note published in October of 2019.
Generating data to support country-introduction
In response to a requirement by the EMA, a large Phase IV study in five African countries to evaluate the safety of Pyramax when used in “real world” settings was undertaken and in 2021, and was published in PLoS Medicine.1 The study concluded that Pyramax demonstrated high real-life safety, tolerability and effectiveness in the treatment of uncomplicated malaria. The study population included patients with acute hepatitis, in addition to those with HIV, malnourished patients, children under 1 year of age and women who were unknowingly pregnant.
In 2018, a study to evaluate the use of Pyramax in asymptomatic carriers was initiated in The Gambia and Zambia. The study is now complete and the results will be submitted for publication in 2021.
In 2012, after a restricted label was granted via the EMA's Article 58 procedure, Pyramax was assessed in a phase IIIb/IV safety and efficacy study in West Africa (WANECAM) over 4 years to increase the availability of "real life" safety data after repeat dosing.2 The study found that the safety profile of Pyramax is similar following re-treatment to that seen with initial treatment. This positive data was instrumental in informing the EMA’s decision to grant a revised label for Pyramax tablets in 2015, removing restrictions on repeat dosing, on use only in areas of high resistance and low transmission, and on requirements for liver-function monitoring.
Promoting the correct use of Pyramax
MMV has worked closely with Shin Poong to facilitate the correct use of Pyramax. Packaging and dosing instructions were field tested in Kenya, India and Senegal to ensure acceptability, relevance and comprehension with caregivers, patients and healthcare workers.
MMV is supporting Shin Poong in facilitating the registration of both tablets and granules at country level, and in educating national policymakers and stakeholders about the appropriate use of this medicine. This includes regional and national scientific briefings throughout sub-Saharan Africa for local stakeholders.