sBLA Filing for Novartis' Menveo Vaccine in Infants Imminent after Positive Phase III Data

Novartis reported positive data from a pivotal clinical trial evaluating its Menveo® meningococcal vaccine in infants. The global study showed that 94–100% of infants vaccinated with four doses of Menveo achieved robust immune responses against Neisseria meningitides meningococcal serogroups A, C, W135, and Y.

Novartis says the positive Phase III data means it now aims to submit a supplemental Biological License Application to FDA by the end of 2010, for approval of Menveo in infants aged 2 months and older. Similar marketing applications are also planned for Europe and other countries worldwide. Menveo was approved earlier this year in the U.S. and Europe for the active immunization of children and adults aged 11 years and older. An sBLA for the use of Menveo in children aged 2–10 years is currently under FDA review.

The latest reported Phase III trial involved 4,545 healthy infants at sites in the U.S. and Latin America. Infants were randomized to receive their routine DTaP, IPV, HBV, Hib, and pneuomococcal vaccinations, either alone or in combination with Menveo at 2, 4, 6, and 12 months of age.

The percentage of Menveo-vaccinated infants achieving a protective immune response a month after the third dose was 67% for serogroup A, 97% for serogroup C, and 96% for serogroups W135 and Y. One month after the fourth dose, the protective immunity rates had reached 94% for serogroup A, 98% for serogroup C, and 100% for serogroups W135 and Y.

While Menveo does not protect against N. meningitides serogroup B infections (MenB), just last month Novartis reported positive data from a Phase III trial evaluating its multicomponent meningococcal serogroup B vaccine candidate 4CmenB. The European study, in 3,600 infants, showed that the vast majority of those vaccinated with 4CMenB at the same time as other routine vaccines achieved a robust immune response against all vaccine MenB antigens.

4CmenB was administered at 2, 4, and 6 months of age. One month after the final 4CMenB dose, the percentage of subjects achieving serum bactericidal antibodies against the three MenB strains 5/99, NZ98/254, and H44/76 were 100%, 84%, and 100%, respectively.

The Novartis 4CMenB vaccine has been developed using an approach Novartis terms reverse vaccinology. The firm says that in contrast to conventional methods of designing vaccines, the reverse vaccinology approach essentially decoded the genetic makeup of MenB to identify specific components that most typically cause infection. The resulting 4CMenB vaccine targets multiple components and has been designed to provide an optimal immune response against the majority of MenB strains, Novartis claims. Additional Phase III trial results from ongoing studies are expected later this year, and the firm expects to file a regulatory submission for MenB in the EU by the end of 2010.

Novartis’ first approved meningococcal vaccine, Menjugate® is a meningococcal C conjugate vaccine approved outside the U.S. since 2000 for use in individuals from 2 months of age through adulthood Novartis says it has already distributed more than 45 million doses of Menjugate around the world. The firm has also developed MeNZB®, as a vaccine against a strain of meningococcus B specific to an outbreak in New Zealand.