FDA accepts Novartis meningococcal vaccine sBLA for review
The US Food and Drug Administration (FDA) has accepted for review Novartis' supplemental biologics license application (sBLA) to expand the Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) indication to include infants and toddlers from 2 months of age.
Menveo is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
The sBLA is supported by data from pivotal trials which included more than 6,000 infants and toddlers.
According to study, 100% of subjects achieved the correlated protection level (hSBA titers >=8) against serogroups W-135 and Y, and 94% and 98% of subjects achieved this level against serogroups A and C, respectively.
The application accepted includes infant data aged 2 to12 months as well as additional data that support the use of Menveo in toddlers from 12 to 23 months of age.
Novartis plans to submit additional data to the European Medicines Agency to support the use of Menveo in infants and children 0 to 10 years of age in the coming months.