Sanofi's Label Update For Flu-Zone High-Dose Gets FDA Green Light

Sanofi’s vaccine division Sanofi Pasteur announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental biologics license application (sBLA) for its influenza vaccine Fluzone High-Dose. The drug will now have efficacy data contained in its prescribing information.

Fluzone High-Dose vaccine is indicated for the prevention of flu caused by influenza A subtype viruses and type B virus, which the vaccine contains. The vaccine is intended for patients aged 65 years and above. The High-Dose form contains four times the amount of antigen contained in the standard dose form.

The company said that the label will now reflect data from efficacy studies showing that Fluzone High-Dose vaccine improved protection (24.2 percent more effective) compared to standard-dose Fluzone vaccine (trivalent intramuscular formulation) in elderly patients. The results indicate that one in four breakthrough flu cases could be prevented if Fluzone High-Dose was used in place of the standard dose Fluzone vaccine in the patient population of 65 years old and above. The data came from a multi-center, large scale, double-blind, post-licensure safety and efficacy trial that took place over the course of two flu seasons.

The company published the results of the trial in The New England Journal of Medicine. “Inclusion of these efficacy data in the Fluzone High-Dose vaccine Prescribing Information validates the importance of this vaccine for people 65 years of age and older. …We urge everyone eligible — especially older adults — to get vaccinated as soon as possible if they have not already done so,” said David P. Greenberg, VP of Scientific & Medical Affairs, and CMO at Sanofi Pasteur U.S.

Phil Hosbach, VP of New Products and Immunization Policy at Sanofi Pasteur, said that the company anticipates discussing the results of the trial with the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, as well as with other health policy-makers. “Given the significance of these results, we believe that Fluzone High-Dose vaccine fills a vital public health need as the only influenza vaccine shown specifically to address the age-related decline of the immune system. Compared to younger adults, people 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness leading to hospitalization and death.”