Prequalification brings this new antimalarial a step closer to patients
The WHO prequalification programme has added Pyramax®, the fixed-dose combination of pyronaridine and artesunate, to its list of approved medicines.
In February 2012, Pyramax® developed in partnership with Shin Poong Pharmaceutical Co. Ltd. and Medicines for Malaria Venture (MMV) became the first antimalarial to be granted a positive scientific opinion from the European Medicines Agency under Article 58. Three months later in May 2012, the World Health Organization (WHO) has also given its stamp of approval for the new artemisinin combination therapy (ACT).
This once daily, 3-day treatment is indicated for acute, uncomplicated Plasmodium falciparum and blood-stage Plasmodium vivax malaria in adults and children over 20 kg. It is the first ACT to be approved by a stringent regulatory authority for the treatment of both of these two main species of malaria.
Via the prequalification process, the WHO assesses and approves the quality, safety and efficacy of medicinal products. The objective is to provide international procurement agencies with a wide selection of quality-assured medicines for purchase. Pyramax can now be included in that selection.
Initially, Pyramax will be registered in areas of low malaria transmission where there is reported artemisinin resistance and diminished efficacy of other ACTs. Until further data after retreatment is obtained, Pyramax use will be restricted to a single course of treatment. Meantime, MMV and Shin Poong are conducting additional studies to investigate the safety of Pyramax after repeat-administration.
The Pyramax dossier has been submitted for regulatory approval to Myanmar and Vietnam, and is currently being processed. It is also being prepared for submission to Cambodia and Thailand.
Once approved in these countries, this ACT will serve as an important public health tool in WHO’s artemisinin resistance containment strategy. The prequalification of Pyramax is a key step towards the achievement of that goal.