GlaxoSmithKline Gets Expanded FDA Win for Fluarix

 GlaxoSmithKline announced today it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FLUARIX^®QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

"The flu vaccine is the one vaccine that people of almost all ages - from 6-month-old infants to older adults - should receive annually," said Patrick Desbiens, Senior Vice President, US Vaccines. "The expanded indication for FLUARIX^® QUADRIVALENT in the US builds upon GSK's commitment to being a reliable supplier and partner to healthcare providers and their patients. We can now offer two flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness."

With this approval, providers will be able to use the same dose of FLUARIX^®QUADRIVALENT (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from 6 months of age and up.

The supplemental Biologics License Application was based on a Phase III pivotal study of the efficacy of FLUARIX^® QUADRIVALENT in children 6 months through 35 months of age and on two supportive studies.