According to the WHO, malaria affected 228 million people worldwide in 2018, resulting in 405,000 deaths. Timely access to the appropriate treatment is key to ensuring a bout of acute uncomplicated malaria does not turn into a severe case.
The newest ACT combination on the market
Pyramax, a fixed-dose combination of pyronaridine and artesunate co-developed by MMV and Shin Poong Pharmaceutical Co. Ltd., South Korea, is the newest ACT combination to be approved by a Stringent Regulatory Authority.
The only ACT approved to treat P. vivax and P. falciparum species of malaria
It 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 is recommended by WHO for adults and children
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 of October 2019.
This once-daily, 3-day therapy is 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).
Evaluating the safety of repeat dosing
After a restricted label was granted in 2012, 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. The safety profile of Pyramax is similar following re-treatment to that seen with initial treatment.1
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. In addition, a positive scientific opinion was granted for Pyramax granules, a child-friendly paediatric formulation.