Novartis Pharma Gets EU Approval For Menveo

Menveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. Menveo was developed using conjugate technology, which was pioneered by Novartis Vaccines in the development of its meningococcal group C conjugate vaccine Menjugate.

Novartis plans to submit additional data to the European Medicines Agency to support the use of Menveo in other age groups.

Novartis said that the marketing authorization was based on data from a pivotal Phase III clinical trial and a non-inferiority study. In the non-inferiority study, immune response was assessed among adolescents 11-17 years of age.

In the study, Menveo was shown to be non-inferior to a quadrivalent meningococcal polysaccharide vaccine (ACWY-PS) for all four meningococcal groups contained in the vaccine. At one year after vaccination, a higher proportion of adolescents who received Menveo had maintained a protective immune response against three of the four meningococcal groups (groups C, W135 and Y) than those who received ACWY-PS.

Further, when evaluated in adults 56-65 years of age, Menveo was shown to be non-inferior to ACWY-PS in all four meningococcal groups contained in the vaccine and statistically superior for groups A and Y. The clinical significance of these findings is unknown.

Andrin Oswald, division head of vaccines and diagnostics at Novartis, said: “Marketing approval for Menveo for people ages 11 and older is the culmination of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect against meningococcal disease. Our priority is to advance the fight against meningitis through innovative vaccines that help save lives.”