PHILADELPHIA, March 23 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced it has submitted a Biologics License Application (BLA) for FluLaval(TM) (Influenza Virus Vaccine) to the U.S. Food and Drug Administration (FDA). If licensed, FluLaval will be used for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B, which are contained in the vaccine.
“GSK is committed to increasing the supply of seasonal flu vaccine to help keep Americans healthy during the flu season,” said Christopher Viehbacher, President, U.S. Pharmaceuticals, GSK. “Influenza is a serious threat to public health and the U.S. has faced recent shortages of vaccine to prevent it. Following last year’s approval of Fluarix, today’s announcement is another important step toward ensuring adequate availability of a critical weapon to fight the flu.”
Fluarix(R) (Influenza Virus Vaccine) was approved by the U.S. FDA on August 31, 2005. GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corporation in December 2005. FluLaval was granted fast-track status by the U.S. FDA in July 2005 and is marketed in Canada under the name Fluviral(TM). If granted U.S. marketing approval for FluLaval, GlaxoSmithKline expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) to the U.S. market for the 2006/2007 flu season.
About Influenza
Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total U.S. population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the United States each year from complications of influenza infection; more than 90 percent of these deaths occurred in persons 65 years of age and older. Influenza can reach epidemic levels and poses a significant threat to public health, particularly among the nation’s oldest and youngest citizens.
Influenza vaccination is the primary method for preventing influenza and its severe complications. 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 influenza virus and the rapid mutations that can occur make annual vaccination necessary.
GlaxoSmithKline: A Leader in Preventing and Treating Influenza
GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic influenza and has recently committed over $2 billion to expand capacity for manufacturing flu vaccine and its antiviral influenza treatment Relenza(R) (zanamivir for inhalation).
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 GlaxoSmithKline at http://www.gsk.com.
GlaxoSmithKline Forward-Looking Statements
Cautionary statement regarding forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995: the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in the company’s Annual Report 2005.
GlaxoSmithKline
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