GSK submits sBLA seeking expanded indication for Flulaval Quadrivalent
Posted: 3 February 2016 | | No comments yet
The submission seeks an expanded indication for Flulaval Quadrivalent in the US for children six months through 35 months of age…
GSK has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Flulaval Quadrivalent (Influenza Vaccine).
This vaccine is currently approved for active immunisation 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 Flulaval 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 one Phase III pivotal study and three supportive clinical studies conducted in children six months through 35 months of age.
GSK has submitted for presentation the results of the pivotal study to the Paediatric Academic Societies for their annual meeting later this year.
According to the US Centers for Disease Control and Prevention (CDC), the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of two years. Each year, many children get sick with seasonal influenza and some of those illnesses result in death. On average 20,000 children under the age of five are hospitalised in the US because of influenza complications. The CDC recommends that everyone aged six months and older get a seasonal flu vaccine.