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FDA asks for more data on Novartis' meningitis vaccine

Second attempt to file Menveo for use in infants under two fails to meet requirements

Novartis will have to provide additional data to the US Food and Drug Administration (FDA) before the agency will consider approving its meningococcal conjugate vaccine Menveo in very young infants.

Menveo is already approved in the US and more than 50 other countries worldwide to provide protection against Neisseria meningitidis strains A, C, Y and W-135 from the age of two upwards.

Novartis filed a second attempt last year to extend the vaccine's use to include infants as young as two months, but in a Complete Response letter the FDA said that the submission still does not meet its requirements.

The agency had already issued a Refuse To File (RTF) notice in January 2011 in the wake of Novartis' first attempt to win approval for the expanded use for Menveo.

The nature of the FDA's concerns with the dossier has not been disclosed, with Novartis saying only that it "requests answers to additional questions". The earlier RTF rejection had been attributed to procedural issues with the application.

Meanwhile, Novartis is not alone in struggling to get approval for a meningitis vaccine in very young infants.

GlaxoSmithKline has been sent two Complete Response letters from the FDA for its MenHibrix candidate, which adds protection against Haemophilus influenza type B - another common cause of meningitis - to meningococcal strains C and Y.

GSK has been trying to get approval for use of MenHibrix in infants as young as six weeks.

At the moment, Sanofi's rival vaccine Menactra has the youngest approved immunisation age in the US at nine months, and routine use at this age was endorsed by a US Centers for Disease Control and Prevention (CDC) advisory committee in October 2011.

Both Novartis and GSK are hoping to secure approval for earlier use, not only to provide protection against meningitis for children under one - a group with the highest rate of meningococcal disease - but also to gain a competitive edge over Menactra.

Sanofi's vaccine achieved sales of €427m ($566m) in 2011, while Menveo made $142m for Novartis.

13th February 2012

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