Sanofi appealed to the FDA to change the labeling of its high-dose Fluzone vaccine to reflect superior efficacy data in people aged over 65, and now it has fresh trial results to back up its case that Fluzone High-Dose provides better protection in individuals in this age group compared to traditional flu jabs.
In August, Sanofi gave a first look at eagerly anticipated data from Phase III comparing its high-dose Fluzone vaccine with a standard jab. The data prompted Sanofi to talk up its chances of getting a label for superior efficacy data in people aged over 65, and this week it began making its case.
In 2009, Sanofi 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.
Sanofi's 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.
As one of the worst flu seasons in a decade sweeps the United States, some flu vaccine and drug manufacturers find themselves in short supply of their products. Still, the high demand offers a welcome financial boost.
A tough year for the flu has run drugmakers short on vaccine and treatment. Still, with demand for flu vaccine and Tamiflu running rampant, it will mean a boost to sales for those companies that make them.
As H1 came to a close, FierceVaccines decided to take a look at which prophylactic vaccines flew off the shelves--and which companies made the sales.
As H1 came to a close, FierceVaccines decided to take a look at which prophylactic vaccines flew off the shelves--and which companies made the sales. Take a look at the full list >>
The FDA says government officials are looking into reports of seizures in patients who'd been given the Sanofi-Aventis influenza vaccine Fluzone. The reports mostly involved children younger than
Sanofi Pasteur this week reported the results of a Phase III clinical trial comparing its investigational Fluzone intradermal candidate with Fluzone administered by the traditional intramuscular