GlaxoSmithKline has filed for approval of its influenza vaccine FluLaval in the USA, setting up a major push into the flu vaccine market.
GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical last year, and the new product is expected to help it capture market share in the US flu vaccine market, blown open by the manufacturing problems that caused Chiron to withdraw its Fluvirin product ahead of the 2004/5 flu season.
FluLaval’s approval would help GSK compete with Sanofi-Aventis, the other major supplier of flu vaccines into the US market, as Chiron struggles to get back on its feet.
The new vaccine has been granted fast-track status by the FDA and is already marketed in Canada as Fluviral. If it is approved, GSK expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and its already-marketed Fluarix product) for the 2006/2007 US flu season.
If licensed, FluLaval will be used for the active immunization of adults 18 years of age and older.