Novartis granted CHMP backing for avian flu vaccine

Novartis has won a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of its pre-pandemic influenza vaccine Aflunov.

The European Medicines Agency committee has backed the ratification of Aflunov as a treatment against the H5N1 subtype of the influenza A virus among adult patients, based on encouraging results from clinical studies.

This recommendation is expected to pave the way for a European marketing authorisation for the drug before the end of 2010, which will in turn support Novartis' plans to file for approval of Aflunov in territories such as Asia.

H5N1 is currently circulating among birds, poultry and other species in many parts of the world and is considered by the World Health Organization to be the most concerning strain among all avian influenza viruses.

Andrin Oswald, head of Novartis' vaccines and diagnostics division, said: "The onset of a pandemic can be very rapid, leaving little or no time to prepare. Vaccinating in advance may prevent the potential devastation of a pandemic outbreak."

This comes in the same month that Novartis also received CHMP backing for approval of its Tobi Podhaler cystic fibrosis treatment.