US FDA licenses Sanofi Pasteur's Fluzone Intradermal; fast-tracks Bayer's regorafenib

Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN), says that the US Food and Drug Administration has approved its supplemental biologics license application (sBLA) for licensure of Fluzone Intradermal (Influenza Virus Vaccine). The vaccine is indicated for active immunization of adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

"The microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization," said Olivier Charmeil, president and chief executive of Sanofi Pasteur.

The new formulation of Fluzone Intradermal vaccine is the first influenza vaccine licensed in the USA that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal vaccine features an ultra-fine needle that is 90% shorter than the typical needle used for intramuscular injection of influenza vaccine. Sanofi Pasteur has previously licensed microinjection intradermal influenza vaccines, marketed as Intanza or IDflu vaccines, in more than 40 countries including Australia, Canada and countries in Europe.