Sanofi to return to FDA with new flu vaccine data

In 2009, Sanofi ($SNY) made its play for the seniors flu vaccine market by introducing Fluzone High-Dose. After running a trial of 30,000 people aged 65 and older, the company is ready to go back to FDA to seek a new label for the vaccine.

The 30,000-person trial was a requirement of the FDA's accelerated approval of the vaccine, which contains 180 micrograms of influenza virus hemagglutinin instead of the 45 mcg usually found in trivalent vaccines. Giving a higher dose is intended to offset the weakening of the immune system in seniors. In 2009, Sanofi showed that the FDA Fluzone High-Dose caused a stronger immune response than its standard vaccine, but the regulator was unsure whether this translated into greater protection against influenza.

Having run a comparative efficacy study between the High-Dose and standard vaccine, Sanofi believes it has enough evidence to go back to the FDA. In the recent trial, Sanofi found Fluzone High-Dose was 24.2% more effective at preventing flu in seniors than its standard vaccine. The result meant the trial met its primary endpoint, and Sanofi plans to submit the data to the FDA early next year. Armed with the full clinical study report, Sanofi will seek a new Fluzone High-Dose label that reflects the superior efficacy data in people aged over 65. The trial also reaffirmed the safety of the vaccine, Sanofi Pasteur VP of scientific and medical affairs Dr. David Greenberg said.

The week before posting the data, Sanofi bolstered its vaccine development assets by acquiring Freeslate's Biologics Formulation System. California-based Freeslate created the system to accelerate development of stable formulations while reducing use of the active ingredient. The tool achieves this goal by automating sample preparation and stressing, as well as formulation analysis.

- check out Sanofi's release (PDF)
- read the Freeslate release (PDF)
- see FiercePharma's take

Special Reports: Sanofi - Top 5 Vaccine Companies by Revenue | Top 10 Flu Vaccines of 2012 | Sanofi - Top Pharma Companies by 2012 Revenues