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GlaxoSmithKline (GSK) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nimenrix® (MenACWY-TT) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

A CHMP positive opinion is one of the final steps before regulatory approval. As part of its assessment, CHMP reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide.

Thomas Breuer, Senior Vice-President, Head of Global Vaccine Development at GSK commented: "GSK has over 20 years experience in developing meningococcal vaccines. This positive opinion represents a major milestone in our development programme and we look forward to receiving the final decision from the EMA in the coming months".

• www.gsk.com