Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) on its application for the expanded use of Menveo® in infants and toddlers from two months of age.
Menveo is already approved for use in individuals aged between two and 55 years in the US.
Novartis submitted the supplemental Biologics License Application (sBLA) for Menveo to the FDA in April 2011.
The Complete Response letter indicates the FDA has completed the current review cycle and requests answers to additional questions prior to proceeding with further review of the sBLA.
Novartis will work with the FDA to address these questions.
As of February 2012, Menveo is registered in more than 50 countries for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
Menveo received the FDA approval for use in adolescents and adults (11 to 55 years of age) in February 2010 and approval for use in children two to 10 years of age in January 2011.
Since launch, more than three million doses of Menveo have been distributed worldwide. Studies are ongoing in infants, toddlers, adolescents and adults.