Novartis receives FDA approval for new meningitis B vaccine

WASHINGTON - Jan. 26, 2015 - PRLog -- Novartis’ new vaccine Bexsero® has been granted accelerated approval by the U.S. Food and Drug Administartion (FDA) for the prevention of bacterial meningitis B in adolescents and young adults from 10 years through 25 years of age. Administraion of Bexsero® consists of a two-dose regimen at least one month apart.

From Phase II and Phase III studies conducted, Bexsero produced an immune response in participants (adolescents and young adults) after two doses. A tolerability profile of Bexsero was conducted at Princeton University and University of California, Santa Barbara (UCSB) in 15, 000 individuals as a part of a US Centers for Disease Control and Prevention (CDC) sponsored clinical trial during a meningitis outbreak at these campuses. Safety data collected from the CDC clinical trial were consistent with results collected from previous clinical studies.  Novartis will continue to conduct studies to assess the effectiveness of Bexsero® against diverse serogroup B strains.

"While rare, meningitis B is a devastating disease that can hit anyone anytime, especially teenagers and children," said Andrin Oswald, Division Head, Novartis Vaccines. "This approval is an important milestone towards our goal of helping to prevent any further loss of life."

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