GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies, has received marketing authorisation from the European Commission (EC) for an additional indication for Synflorix for the immunisation against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age.
This approval was based on results from a phase III double-blind, randomised, controlled trial named COMPAS. This efficacy study for a latest-generation pneumococcal conjugate vaccine (PCV) was conducted in 63 centres in South America, involving 24,000 children.
“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 pneumoniae.”
Synflorix is currently approved in the EU and 90 other countries for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. Around 40 countries have chosen Synflorix in their universal mass vaccination programmes and 67 countries already have an approved indication for pneumonia. Synflorix is not approved for use in the US.
GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
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