GlaxoSmithKline seeks US FDA approval for flu vaccine

26 March 2006
DELHI, INDIA

GlaxoSmithKline, the world's second largest drugmaker, said it has submitted a Biologics License Application (BLA) for FluLaval (Influenza Virus Vaccine) to the US 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.

Observing influenza is a great threat to the public, GSK said in a press release that the company is committed to increasing the supply of seasonal flu vaccine to help keep Americans healthy during the flu season. ``Following last year’s approval of Fluarix, this is another important step toward ensuring adequate availability of a critical weapon to fight the flu.''

Fluarix (Influenza Virus Vaccine) was approved by the US 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 US FDA in July 2005 and is marketed in Canadaunder the name FluviralTM. If granted US 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.

Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total US 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 has an active research and development programme 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 (zanamivir for inhalation).