Tag: Pediatrics

24 Feb 2016

FIRST PAEDIATRIC ANTIMALARIAL TO RECEIVE EMA ARTICLE 58 POSITIVE SCIENTIFIC OPINION

The first paediatric antimalarial that has been granted a positive scientific opinion from the European Medicines Agency (EMA), under Article 58 is Pyramax® Granules. Pyramax® Granules is a fixed-dose artemisinin combination therapy (ACT) of pyronaridine and artesunate. With this opinion, the registration and use of Pyramax® Granules on children in malaria stricken areas will be supported.

Given the fact that a child would need to complete the full dose in order to attain a cure, it is appropriate that the granule formulation is taste-masked, suspends in only 2 teaspoons of liquid and only requires a once daily dose for 3 days, making treatment compliance simple for sick children.

According to Medicines for Malaria Venture’s CEO, David Reddy, “Around 78% of people dying from malaria are children less than 5 years of age. The timely development of age-appropriate formulations to address the needs of this particularly vulnerable population is essential. Following this positive scientific opinion from EMA, MMV, Shin Poong and other partners can work with endemic countries to pursue national approvals for Pyramax Granules and make the medicine available to children in need.”

Jei Man Ryu, CEO of Shin Poong Pharmaceutical, commented the following, “We are proud to have reached this landmark achievement with our long-standing partner Medicines for Malaria Venture. We have worked with dedication to achieve this goal and will continue to collaborate with MMV to ensure that this important life-saving medicine reaches the children for whom we developed it. Unacceptable numbers of children continue to die of malaria and this medicine will be of enormous benefit to those children suffering from either P. vivax or P. falciparum blood-stage malaria.”

For more information on this, please go to: http://www.mmv.org/newsroom/press-releases/pyramax-granules-becomes-first-paediatric-antimalarial-receive-ema-article