GlaxoSmithKline (GSK) has filed two new influenza vaccines for regulatory approval.
Its quadrivalent influenza vaccine, which has yet to be approved in its first market, has been submitted to the US Food and Drug Adminstration (FDA) and the European Medicines Agency (EMA).
GSK is seeking approval for the vaccine to be used in adults and children from three years of age against influenza disease caused by influenza virus types A and B that are contained in the vaccine.
The pharma company submitted a supplemental Biologics License Application to the FDA and filed a new application to the EMA.
Pandemic flu vaccine
Meanwhile, GSK has also submitted its H5N1 pandemic flu vaccine to the FDA for use in adults “as directed by the US Government”.
GSK's H5N1 influenza vaccine programme was supported by a development contract with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services.
That vaccine was approved in March, 2011 in Europe, where it is marketed under the brand name Pumarix and GSK's biologics unit has a five-year marketing authorisation from the European Commission.