Pyronaridine-artesunate granules

Access

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Approved

Pyramax® granules

Shin Poong

Paediatric formulation

3-day cure, artemisinin-based combination therapies (TPP-1)

Therapeutic indication	For the treatment of uncomplicated malaria infection caused by P. falciparum or P. vivax in children and infants weighing 5 kg to under 20 kg
Dosing	Once-daily for 3 days
Efficacy	28-day PCR-corrected ACPR* >97% 42-day PCR-corrected ACPR* 90%–95%
Key features	Only artemisinin-based combination therapy approved by a stringent regulatory authority for both P. falciparum and P. vivax (blood-stage) No food restrictions 2-year shelf life Child-friendly granules
Challenges	Country order fulfilment by major procurement bodies
Status	Included in WHO Essential Medicines List for children & Included in WHO Guidelines for Malaria October 2022 Positive opinion from European Medicines Agency (Article 58). Cross-listed on WHO list of prequalified medicines Approved in 21 countries & Included in 11 national treatment guidelines Ongoing phase III study to assess safety and efficacy in mild to moderate Covid-19 patients (adult population)
Next milestone	Continued commercial introduction in malaria-endemic countries Approval of 30-month shelf life
Previously	Development project team led by University of Iowa
Project Director	Adam Aspinall

* ACPR = adequate clinical and parasitological response