In another setback to its competitive positioning, Novartis AG’s quadrivalent meningococcal conjugate vaccine Menveo has received a “complete response” letter from FDA for an application that would have expanded use to children aged between two months and two years of age.

FDA wants additional data to support use in this age group to support approval, Novartis said Feb. 13. The vaccine is currently approved for preventing meningococcal disease caused by Neisseria meningitides serogroups A, C W-135 and Y in people aged two to 55 years old. These four strains account for 43% of cases of disease in infants and 67% in adolescents and young adults.

FDA initially issued a refuse-to-file letter for the sBLA, in January 2011; Novartis resubmitted its application in April. 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,” the company said in a statement. [This story was updated Feb. 14; a previous version incorrectly cited a different company.]

Novartis is not revealing further details at this time.

Expansion to different age groups represents a key part of competitive strategy for vaccine makers. Menveo sales amounted to $142 million in 2011, compared to €427 million ($594 million) for Sanofi’s rival vaccine Menactra, which has an 84% market share in the U.S., noted Bryan Garnier analyst Eric Le Berrigaud in a Feb. 13 note.

In April, FDA approved an sBLA for Menactra in children over nine months of age, but it was unclear whether this would spur greater use unless there were a change in guidelines Also see "Expanded Label For Sanofi Pasteur's Menactra May Lead To Only Limited Market" - Pink Sheet, 25 April, 2011.. Approval of the Menveo sBLA for children over the age of two months “could have been a differentiating factor against Menactra, though recommendations would have to change to allow earlier use,” Le Berrigaud observed.

FDA is open to use of meningitis vaccines in very young children; it released guidance on development, including a recommendation to use an immune response biomarker to prove efficacy, in March 2011 Also see "Meningococcal Vaccine Development To Get FDA Advisory Cmte. Review" - Pink Sheet, 11 March, 2011.. FDA suggested use of serum bactericidal antibody measurements to predict protection for children under the age of two, a recommendation that was endorsed by an advisory committee panel in April 2011.

Novartis says its sBLA was supported by data from pivotal trials that included more than 6,000 infants and toddlers worldwide. In a trial measuring immune response to the vaccine one month after a completion of a four-dose Menveo series at 2, 4, 6 and 12-16 months of age, 100% of trial participants achieved the correlated protection level (hSBA titers ≥8) against serogroups W-135 and Y, while 94% and 98% of subjects achieved this level against serogroups A and C, respectively. Menveo was generally well tolerated when administered alone or with other pediatric vaccines, the company said.

Novartis’ Expansion Of Menveo Further Set Back By “Complete Response”

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