GSK announces US regulatory submission seeking expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 mos+
GSK today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration 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 Pediatric Academic Societies for their annual meeting on 30 April 30-3 May, 2016 in Baltimore, MD.
About seasonal influenza in children
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. Most flu activity in the U.S. occurs from October-May, and it usually peaks in January and February.
According to the U.S. 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 because of influenza complications. The CDC recommends that everyone aged six months and older get a seasonal flu vaccine.
About FLULAVAL® QUADRIVALENT
FluLaval® Quadrivalent was first approved in 2013 in the U.S. for the prevention of influenza disease in people three years of age and older. In addition, it is also approved in two other countries, Canada (as FluLaval® Tetra) and Mexico (as FluZactal® Tetra), for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine in people six months of age and older.
For the full U.S. Prescribing Information for FLULAVAL® QUADRIVALENT, visit GSKsource.com.
GSK - one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.