GlaxoSmithKline announced Monday the submission of a regulatory filing to the European Medicines Agency seeking expanded approval of Synflorix for active immunisation against pneumonia caused by Streptococcus pneumoniae in infants and children aged six weeks to five years.
The pneumococcal vaccine was approved in Europe in 2009 for active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae. As well as in the EU, Synflorix is authorised in 90 other countries for this indication and 67 markets have also cleared the vaccine for active immunisation against pneumonia.
GlaxoSmithKline noted that it has not filed for FDA clearance of Synflorix and has previously indicated that it may not attempt to sell the vaccine in the US market.
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