Malaria: Pyramax granules (pyronaridine-artesunate) for children added to WHO list of prequalified medicines

Pyramax® granules (pyronaridine-artesunate) for the treatment of uncomplicated malaria in children from 5-20kg was added to the World Health Organization's (WHO) list of prequalified medicines in March 2016. This follows the European Medicines Agency's (EMA) decision to grant the medicine a positive scientific opinion through its Article 58 procedure in November 2015 - making Pyramax granules the first fixed-dose artemisinin combination therapy (ACT) developed specifically for children to be granted this opinion through article 58.

Simultaneous with its review of Pyramax granules, the EMA also authorized significantly expanded use of Pyramax tablets for patients >20kg. While this medicine was first granted a positive scientific opinion by the EMA in 2012, the new label expands the possibility of Pyramax's deployment in all malaria-endemic countries, allowing for repeated treatments.

Pyramax is the result of a product development partnership between Medicines for Malaria Venture (MMV), and Shin Poong Pharmaceutical Co. Ltd., Republic of Korea. Beginning in 2002, this drug development programme led to the testing of Pyramax in over 3,500 malaria patients in clinical studies in 18 countries in Africa and Asia, in which the medicine has shown high efficacy - similar to existing WHO-recommended ACTs.

Following the EMA's initial positive scientific opinion in 2012, Pyramax was included in an extensive Phase IIIb /IV trial conducted by the West African Network for Antimalarial Drugs (WANECAM) from 2011-2016. Publication of a sub-analysis of the findings in the Lancet Infectious Diseases in October 2015¹ reconfirmed the safety and efficacy of Pyramax, even when re-dosed up to 8 times in a single patient over a 2-year follow-up period.

Pyramax's key attributes:

• In line with WHO's guidance on making Better Medicines for Children², Pyramax granules, was developed expressly for palatability and ease-of-use in children, the most vulnerable population facing the gravest risks from malaria.
• Pyramax is the only ACT included in the WHO list of prequalified medicines to have been evaluated in pivotal Phase III studies for efficacy in clearing P. vivax infections, in addition to P. falciparum infections.
• Pyramax has a long duration of action, which provides a useful period of post-treatment protection against reinfection.³
• Pyramax is a once-a-day medicine administered over 3 days.
• Pyramax is not subject to "food effects", meaning that its effectiveness is not impacted by the presence or absence of fat-containing drinks or solid foods.⁴
• Pyramax shows comparable efficacy to the four fixed-dose ACTs currently recommended by WHO⁵ for curing uncomplicated malaria.

Pyramax tablets are currently approved in 14 countries in Asia and Africa. MMV and Shin Poong will work with partners to support further endemic-country registrations and first-time registration of Pyramax granules. In 2016, a Phase IV pharmacovigilance study will be initiated, generating additional data about Pyramax's use in real-life settings.

"Malaria control is at a critical juncture," said David Reddy, MMV's CEO. "Since 2000 the number of clinical cases of malaria has fallen by 18% and the malaria mortality rate is estimated to have fallen by 60%. But we need new tools to continue winning in the fight against malaria. As the newest medicine designed specifically for the treatment needs of the youngest most vulnerable patients, Pyramax granules will make a critical contribution to curing patients and saving lives."

"We at Shin Poong are proud that our partnership with MMV has resulted in EMA and WHO inclusion of Pyramax, in the family of quality-assured antimalarial medicines" said Mr Won June Chang, CEO of Shin Poong. "We ventured into the Pyramax project guided by Shin Poong's core values to work for the health of people everywhere. We will now work with MMV to register both the tablets and granules of Pyramax in malaria-endemic countries and ensure uptake of this alternative and effective option."

"Pyramax presents an excellent addition to current ACTs," said Prof. Abdoulaye Djimdé, WANECAM Project Coordinator at MRTC, Bamako, Mali. "Not only can it be administered to patients of all ages from infants to adults, but it is easy to take, the patient requires no further treatment in 28 days, needs no additional monitoring and it can be given again to patients who suffer from repeated bouts of malaria. Pyramax will be a most welcome additional weapon for our fight against malaria".