GlaxoSmithKline (GSK) has received approval from European Regulators in 15 EU countries for use of its anti-viral Relenza (zanamivir for inhalation) in the prevention (prophylaxis) of influenza A and B in adults and children 5 years of age and above.
Approval was also received for the treatment of influenza in children 5 years of age and above. Relenza is already approved in Europe for the treatment of influenza in adults and adolescents 12 years of age and above, a GSK press release stated.
Relenza won US FDA approval for the prevention of influenza in adults and children aged 5 years and older in March 2006.
"This approval is a significant step forward as it provides the medical community in Europe with another option to prevent and treat seasonal influenza enabling governments to prepare for a potential flu pandemic," said David Stout, President Pharmaceutical Operations, GSK. "As a leading provider of vaccines and anti-viral medications, GSK is committed to support governments and health authorities around the world in planning to respond to a global crisis should an influenza pandemic occur."
GlaxoSmithKline has an active research and development programme targeted at both seasonal and pandemic influenza, and has committed over $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza, the release added.