Novartis announced that the FDA has approved Menveo (meningococcal [Groups A, C, Y, W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for the active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11–55 years of age. This approval was based on study results from a Phase 3, head-to-head trial that compared Menveo to other US-licensed ACWY meningococcal conjugate vaccines in two patient populations – adolescents, age 11–18, and adults, age 19–55.
In study participants aged 11–18 years, the percentages of subjects who demonstrated an immune response (ie, achieved an hSBA titer ≥1:8) for each serogroup for Menveo and its comparators respectively, were: serogroup A – 75%:67%; serogroup C – 84%:84%; serogroup Y – 88%:69%; and serogroup W-135 – 96%:88%. The seroresponse with Menveo for serogroups A, Y and W-135, was statistically higher. However the clinical relevance of higher post-vaccination immune responses is not known.
Menveo is expected to be available by the end of March 2010.
For more information call (617) 871-5500 or visit www.novartisvaccines.com.