US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine

Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics License Application with the US Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone (influenza virus vaccine). The sBLA file has been accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013.

"The addition of a fourth influenza virus strain to the seasonal influenza vaccine formulation has the potential to make a substantial impact in reducing influenza disease and influenza-related complications, hospitalizations and deaths among those who contract the disease," said David Greenberg, senior director, US scientific and medical affairs, at Sanofi Pasteur. "Two influenza B-lineage strains typically co-circulate in the USA each year, so it makes sense to include both in the vaccine rather than attempting to predict which of the two will be the dominant strain. In fact, in six of the past 12 influenza seasons, the B strain selected by health authorities for inclusion in the vaccine was not the predominant B-lineage strain that circulated during the next influenza season," he added.

Sanofi Pasteur is seeking FDA licensure of Fluzone Quadrivalent Influenza Virus Vaccine for active immunization of children and adults six months of age and older for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This is the same age indication for Sanofi Pasteur's currently licensed trivalent influenza virus vaccine, Fluzone vaccine. Fluzone vaccine is used in the U.S. to help protect more than 50 million people each year against influenza and is the only influenza vaccine licensed in the USA for children as young as six months of age. While influenza B can affect people of any age, it is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children.