GlaxoSmithKline (GSK) announced that the European Commission (EC) has granted marketing authorization for an additional indication for Synflorix for the immunization against pneumonia caused by Streptococcus pneumonia in children from six weeks up to five years of age.
This approval was based on results from a Phase 3 double-blind, randomized, controlled trial named COMPAS. This efficacy study for a latest-generation pneumococcal conjugate vaccine (PCV) was conducted in 63 centers in South America, involving 24,000 children.
The EU Summary of Product Characteristics for Synflorix is available online. (https://ec.europa.eu/health/documents/community-register/html/h508.htm)
“GSK welcomes this approval for an additional Synflorix indication in Europe,” said Thomas Breuer, senior vice president and lead physician, GSK Vaccines. “Pneumonia continues to kill more children under five than AIDs, malaria and measles combined and affects both the developed and the developing world. There are three million cases of pneumonia in children under five in Europe each year. With this new indication, we are confident that Synflorix will contribute to a significant reduction in cases of pneumonia caused by Streptococcus pneumonia.”
Date: December 5, 2013
Filed Under: Drug Discovery