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GEN News Highlights : Mar 18, 2010

EC Clears Novartis’ Quadrivalent Meningitis Vaccine

Green light in Europe follows less than a month after FDA approval.

The European Commission granted pan-European clearance for Novartis’ quadrivalent meningitis vaccine, Menveo® (meningococcal group A, C, W135, and Y conjugate vaccine). The European decision comes less than a month after the vaccine was sanctioned by the FDA.

Approval of Menveo in Europe covers use of the vaccine for the active immunization of adolescents (aged 11 years and over) and adults at risk of exposure to Neisseria meningitides groups A, C, W135, and Y. Novartis says Menveo represents the first conjugate vaccine commercially available in Europe to help protect against four major groups of meningococcal disease. The firm plans to submit additional data to the EMEA in support of the use of Menveo in other age groups.

Menveo is based on the same technology as Novartis’ Menjugate® vaccine, a meningococcal serogroup C conjugate vaccine approved outside the U.S. since 2000. Novartis also has another meningitis vaccine in development, MenB. It is currently in European Phase III trials against B serogroup meningococcal meningitis.