Therapy Areas: Vaccines
GSK awarded US FDA approval for expanded indication for FLUARIX QUADRIVALENT (Influenza Vaccine) for persons six months and older
15 January 2018 -

Healthcare company GSK (LSE:GSK) (NYSE:GSK) reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research for the expanded use of FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons six months and older.

The FLUARIX QUADRIVALENT (Influenza Vaccine) vaccine was previously only approved for active immunization against influenza A subtype viruses and type B viruses, in persons three three years of age and older.

Following this US FDA approval, the 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 six months of age and up, added the company.

This supplemental Biologics License Application was based on the company's Phase III pivotal study of the efficacy of FLUARIX QUADRIVALENT in children six months through 35 months of age and on two supportive studies.

Seasonal influenza (the flu) is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness.