Firm will, however, have to resubmit sBLA for Menveo vaccine in 2–12 month age group.
FDA has approved Novartis’ quadrivalent meningococcal conjugate vaccine, Menveo®, for use in children from 2–10 years of age. However, the firm also received a refuse to file (RTF) letter from the agency relating to its November 2010-filed sBLA for clearance of Menveo in infants aged 2–12 months.
The firm says it plans to resubmit this sBLA this year. It also aims to submit data to the EMA during the first half of 2011 to support European approval of the vaccine in the 0–10 years age group. A label extension for the 2–10 years age group has already been submitted in Canada.
Menveo is designed to prevent invasive meningococcal disease caused by Neisseria meningitides serogroups A, C, Y, and W-135. The latest approval for Menveo in children aged 2–10 years of age was based on data from a Phase III trial involving nearly 5,300 children. The study compared the safety and immunogenicity of Menveo against each of the four serogroups it is designed to protect against with the safety and efficacy of the other currently U.S.-licensed ACW-135Y meningococcal conjugate vaccine.
Menveo is now registered in over 40 countries for use in people over 11 years of age. Initial FDA clearance for use of the vaccine in adolescents and adults aged 11–55 years was granted in May 2010.