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Novartis Announces FDA Acceptance of Menveo Supplemental Biologics License Application

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) from Novartis to expand the Menveo(R) meningococcal vaccine indication to include infants and toddlers from 2 months of age. Menveo is already approved in the US for use in individuals 2 years to 55 years of age.

The sBLA is supported by data from pivotal trials which included more than 6,000 infants and toddlers worldwide. In one of the trials, 100% of subjects achieved the correlated protection level against serogroups W-135 and Y, and 94% and 98% of subjects achieved this level against serogroups A and C, respectively. Menveo was generally well tolerated when administered either alone or with other pediatric vaccines.

Key Takeaways:

  • The FDA has accepted a supplemental Biologics License Application (sBLA) from Novartis to expand the Menveo(R) meningococcal vaccine indication to include infants and toddlers from 2 months of age.
  • The sBLA is supported by data from pivotal trials which included more than 6,000 infants and toddlers worldwide.
  • In one of the trials, 100% of subjects achieved the correlated protection level against serogroups W-135 and Y, and 94% and 98% of subjects achieved this level against serogroups A and C, respectively.
  • Menveo is already approved in the US for use in individuals 2 years to 55 years 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.
  • The highest rates of meningococcal disease occur early in the first year of life, with most cases occurring within the first 7 months.
  • About one in 16 infants who contract meningococcal disease may die, and survivors may suffer permanent brain damage, learning disabilities, hearing loss, and limb loss.
  • The resulting side effects require life-long, expensive medical treatment and ongoing assistance.

Statistics:

  • 6,000 infants and toddlers worldwide participated in pivotal trials supporting the sBLA.
  • 100% of subjects achieved the correlated protection level against serogroups W-135 and Y.
  • 94% of subjects achieved the correlated protection level against serogroup A.
  • 98% of subjects achieved the correlated protection level against serogroup C.
  • The highest rates of meningococcal disease occur within the first 7 months of life.

Sources:

  • Novartis Data on File.
  • Centers for Disease Control and Prevention. Vaccines and Preventable Diseases. Factsheet: Meningococcal Diseases and Meningococcal Vaccines. August 2009.
  • Novartis. Menveo(R) Full Prescribing Information. January 2011.
  • Klein NP, Gill CJ, Bedell L, Karsten A, Dull PM. Pivotal safety and immunogenicity of an investigational quadrivalent meningococcal vaccine (MenACWY-CRM; Menveo(R)) in 4545 infants. Presented at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia, Canada on October 21-24, 2010.

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