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news.GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) to expand FluLaval Quadrivalent (influenza vaccine) indication.
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According to approval from the FDA’s Center for Biologics Evaluation and Research, the treatment can now be used among infants of six months or older.
Before this approval, the active immunization vaccine against influenza A subtype and type B viruses was only permitted for use in patients, three years of age or above.
GSK said that extended biologics license application was based on one of its phase III pivotal study.
The company also backed the application by three supportive clinical trials conduction in infants, aged six months through 35 months.
GSK US vaccines senior vice president Patrick Desbiens said: “Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness.
“This expanded indication builds upon GSK’s commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the US market.”
FluLaval Quadrivalent was initially approved in 2013 in the US to avoid influenza disease in people three years of age and older.
It indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
The vaccine is also approved in Canada and Mexico for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine in people 6 months of age and older.
Image: GlaxoSmithKline at 3 Franklin Plaza at the corner of Vine Street and N. 16th Street in Center City, Philadelphia. Photo: courtesy of Beyond My Ken.