FDA Approves New Labeling for Sanofi Pasteur’s Fluzone Flu Vaccine

The FDA has cleared new prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine, indicating it provides improved protection for adults 65 years and older.

The agency’s approval of Sanofi’s sBLA stems from a trial that found the product was roughly 24 percent more effective than standard-dose Fluzone in preventing laboratory-confirmed influenza caused by any viral type or subtype. The data indicates the high-dose version could help prevent about one in four cases of influenza, if used instead of the standard-dose version in the 65-and-older population.

Fluzone High-Dose is the only flu vaccine shown specifically to address the age-related decline of the immune system, Phil Hosbach, Sanofi vice president of new products and immunization policy, said yesterday.

Adults aged 65 and older typically account 60 percent of influenza-related hospitalizations and 90 percent of influenza-related deaths.

Fluzone High-Dose won approval in December 2009. In June, the FDA approved Sanofi’s sBLA for Fluzone Quadrivalent influenza vaccine, which immunizes against four flu strains. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.