Novartis’ Menveo Vaccine Gains Approval

Novartis received approval from the FDA for Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.

“The FDA approval of Menveo is an important milestone for adolescent immunization in the U.S. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease,” said Andrin Oswald, head of Novartis Vaccines and Diagnostics. “Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. For this reason, we are dedicated to helping eradicate meningococcal disease in the U.S. and around the world.”

The approval was based on a Phase III trial that compared Menveo to the other U.S.-licensed ACWY meningococcal conjugate vaccine in subjects 11 to 55 years of age. The trial measured for each of the four serogroups and the percentage of subjects who achieved an immune response. The study also examined antibody level as measured by geometric mean titers (GMT).