GlaxoSmithKline’s Synflorix receives new pneumonia approval in EU

GlaxoSmithKline has announced that its pneumonia vaccine Synflorix has been approved for a new indication in the EU.

The European Commission has approved the drug for use in immunisation against pneumonia caused by Streptococcus pneumoniae in children from six weeks up to five years of age.

This decision was based on positive findings from the phase III trial Compas, a double-blind, randomised, controlled trial conducted in 63 centres across South America, which involved 24,000 children.

Synflorix has been approved in more than 90 countries, with around 40 of these having chosen the product for use in their universal mass vaccination programmes.

Thomas Breuer, senior vice-president and lead physician of GlaxoSmithKline Vaccines, said: "With this new indication, we are confident that Synflorix will contribute to a significant reduction in cases of pneumonia caused by Streptococcus pneumoniae."

This comes after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended a new two-dose schedule for GlaxoSmithKline's cervical cancer vaccine Cervarix for approval last week.