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Fluarix Quadrivalent

Generic name: influenza virus vaccine, inactivated
Treatment for: Influenza Prophylaxis

GlaxoSmithKline Submits Biologics License Application for FDA Approval of Fluarix


New Vaccine Candidate Would Increase Supply of Flu Vaccine in the U.S.

PHILADELPHIA, May 25, 2005 -- GlaxoSmithKline today announced it has submitted a Biologics License Application for Fluarix [Influenza Vaccine (split virion, inactivated)] to the U.S. Food and Drug Administration. 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(R) 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, US Pharmaceuticals, 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."

Fluarix is currently available in more than 75 countries.

About Influenza
Influenza is a highly contagious and potentially fatal virus that affects millions of people each year in the U.S. The flu can reach epidemic levels and poses a threat, particularly to the nation's oldest and youngest citizens. Many respiratory diseases occur every winter but influenza is one of the most severe. Influenza affects 10 to 20 percent of the total U.S. population during seasonal epidemics, resulting in approximately 36,000 deaths in the United States each year.

Influenza is easily passed from one person to another through the air by tiny droplets and particles released when an infected individual coughs or sneezes. Most people recover fully within a week or two. The risk of complications is elevated in very young, very old and chronically ill persons. The genetic makeup of the disease and the rapid mutations that occur make it impossible to eradicate.

"Influenza vaccine is the most important tool we have to control a highly communicable infection that threatens young and old alike," said Dr. John Treanor, professor of Medicine and of Microbiology and Immunology, University of Rochester School of Medicine and Dentistry, 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 United States."

GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
For company information, visit the GlaxoSmithKline website.

Posted: May 2005

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Fluarix Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

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