Sanofi eyes superiority claim for Fluzone High-Dose after trial boost

Sanofi's ($SNY) high-dose formulation of Fluzone scored in a new trial in seniors. The study pitted Fluzone High-Dose against the regular formula and found that the amped-up version offered 24% better protection in patients 65 and older.

The data gives Sanofi Pasteur, the French drugmaker's vaccines business, a marketing hook for the higher-dose formula, which was approved in 2009. The company plans to submit the data to the FDA by early next year in hopes of adding a superiority claim to Fluzone High-Dose's label.

Flu vaccines have shown to be less effective in patients 65 and older, who are at greater risk of complications from flu than younger adults. "[O]lder adults still have the highest rates of influenza-related hospitalization and death despite having high immunization rates," Sanofi Pasteur SVP John Shiver said in a statement.

The new data comes from a 30,000-patient, two-season trial ordered by the FDA to confirm Fluzone High-Dose's efficacy in this age group. The vaccine was originally reviewed under the agency's accelerated approval program, and follow-up studies are routinely required.

Fluzone and its sister product, Vaxigrip, were far and away the biggest-selling influenza vaccines last year. But the field is getting more competitive, with Sanofi, GlaxoSmithKline ($GSK) and MedImmune all ready with new quadrivalent versions of their immunizations. And as the population around the world ages, demand is expected to grow. The holy grail in the business continues to be a universal vaccine that can protect against flu, whatever the virus strain.

- get the release from Sanofi (PDF)
- see the RTT News story

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