GSK seeks FDA approval for Fluarix

If licensed, Fluarix will be used for the active immunization of adults against influenza disease caused by influenza virus types A and B contained in the vaccine. Fluarix will be available exclusively in prefilled TipLok syringes.

“Right now a limited number of companies supply injectable flu vaccine to the entire nation, making the system vulnerable when there are problems with supply as we saw last flu season,” said Christopher Viehbacher, president of US pharmaceuticals at GlaxoSmithKline. “We’re happy to be once again working closely with the Department of Health and Human Services and the FDA to help fill this void in public health, and with FDA approval, we’re committed to making Fluarix available before the next flu season.”

“Influenza vaccine is the most important tool we have to control a highly communicable infection that threatens young and old alike,” added Dr John Treanor, professor of medicine and of microbiology and immunology at the University of Rochester School of Medicine and Dentistry in Rochester, New York. “The potential introduction of another supply of safe and effective influenza vaccines is especially welcome now as we try to improve flu vaccination rates in the US.”

Fluarix is currently available in more than 75 countries.