FDA wants more info on Menveo; advisory negative on Dacogen

Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter from the US Food and Drug Administration on its application for the expanded use of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) in infants and toddlers from two months of age. Menveo is already approved in the USA for use in individuals two to 55 years of age.

Novartis submitted the supplemental Biologics License Application for Menveo to the FDA in April 2011, following a Refuse to File letter from the agency for use of the vaccine in infants (The Pharma Letter January 31, 2011). The news Complete Response letter indicates that 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 agency to address these questions.

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