Synflorix™ receives European marketing authorisation for additional pneumonia indication
GlaxoSmithKline (GSK) today announced that the European Commission (EC) has granted marketing authorisation 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.
For the EU Summary of Product Characteristics for Synflorix, please visit http://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 pneumoniae.”
Notes to Editors:
About Synflorix
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 U.S.
Important safety information
The most common adverse reaction observed after primary vaccination with Synflorix in infants was redness at the injection site and irritability. For further important safety information about the currently licensed indications for Synflorix, please visit the Electronic Medicines Compendium to view the Synflorix EU Patient Information Leaflet.
About pneumonia
Globally, it is estimated that more than 150 million children under five suffer from pneumonia every year [1], and almost 1.1 million children under five years of age die worldwide [2]. Streptococcus pneumoniae is the major bacterial pathogen in pneumonia. Streptococcus pneumoniae is thought to be responsible for 30%–50% of pneumonia cases1.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012. |
[1] Rudan I, et al. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ 2008; 86:408–16.
[2] Committing to Child Survival: A Promise Renewed, UNICEF Progress Report 2013 http://www.unicef.org/publications/files/APR_Progress_Report_2013_9_Sept_2013.pdf (Last accessed Dec 2013).
