GlaxoSmithKline yesterday said it has won US Food and Drug Administration approval to market its flu vaccine, Fluarix, boosting the country’s stocks ahead of the 2005/2006 flu season. The FDA granted the license under a special fast-track approval system, which will entail GSK conducting follow-up studies to verify that the level of protective antibodies does in fact translate into flu protection.

Last year, the USA was left hanging after drug regulators in the UK found deficiencies at Chiron’s manufacturing plant in Liverpool, and put a hold on any shipments to the States [[06/10/04b]]. Chiron’s Fluvirin represented half of the USA’s anticipated stocks, leaving it struggling to plug the gap: the country had been reliant on two major suppliers, Chiron and Sanofi-Aventis, and a smaller contribution from MedImmune nasal vaccine, FluMist.

Fluarix is not a new product and is already distributed in 79 countries, however GSK had never previously pursued approval in the USA on the grounds that the market was already saturated and it would not be able to capture significant market share [[12/10/04a]]. With the growing concern of an influenza pandemic, however, companies are certain to find a foothold in this burgeoning marketplace, and GSK sought US approval in May this year [[26/05/05a]].

Influenza is a highly contagious and potentially fatal virus that affects 5%-20% of the total US population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the USA every year from complications of influenza infection.

Jean-Pierre Garnier, CEO of GlaxoSmithKline, commented. “GSK worked quickly with government officials to make Fluarix available and increase supply at a critical time.” The company has also recently refocused attention on its oral influenza drug Relenza (zanamivir), in the wake of fresh worries over an outbreak of avian flu. Reports have suggested that GSK is planning to expand the labeling for Relenza to include influenza prevention. The news will please originator Biota Holdings, which is suing the UK giant on the grounds that it has failed to properly support Relenza. One of its gripes was that GSK did not pursue a claim for flu prevention [[250805a]], [[28/07/05e]].

"Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health," Health and Human Services Secretary Mike Leavitt said in a statement. “Previous shortages highlighted the need for additional influenza vaccine manufacturers for the US market,” added FDA Commissioner Lester Crawford. “Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines.”