GSK Seeks Expanded Indication for Fluarix® Quadrivalent for Infants Six Months and Older

GSK has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for FLUARIX^® QUADRIVALENT (Influenza Vaccine). This vaccine is currently approved for active immunization against influenza A subtype viruses and type B viruses, in persons three years of age and older. The submission seeks an expanded indication for children six months through 35 months of age. With this approval, providers would 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 six months and up.

The sBLA application is based on a Phase III pivotal study of the efficacy of FLUARIX^® QUADRIVALENT in children six months through 35 months of age and on two supportive studies. GSK has submitted the results of the pivotal study to the European Society for Paediatric Infectious Diseases for presentation at their annual meeting on May 23 - 27, 2017, in Madrid.