GlaxoSmithKline receives European authorisation for Nimenrix™

GlaxoSmithKline plc (GSK) announced today that the European Commission has granted marketing authorisation for Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Thomas Breuer, Senior Vice-President, Head of Global Vaccine Development at GSK, commented: “GSK is pleased to have received approval in Europe for Nimenrix and looks forward to making this vaccine available to help protect individuals against what can be a life threatening disease.”

About Nimenrix

Nimenrix is the first quadrivalent conjugate vaccine to be approved in Europe for active immunisation of individuals from 12 months of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W -135 and Y. Nimenrix is provided as one dose and is generally well tolerated.

Detailed information on the use of Nimenrix and its safety profile are described in the Summary of Product Characteristics, which will be published on the EMA website, together with the European Public Assessment Report (EPAR, http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission’s website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).

About Neisseria meningitides

Neisseria meningitidis is a highly contagious disease with potentially disabling consequences such as deafness, epilepsy and other neurological disorders; in severe cases it can even be life-threatening. The highest risk of contracting the disease is in infants and toddlers in the first 4 years of their lives, with a second peak in adolescents. Certain groups such as travellers to areas with high endemic levels of meningococcal disease (e.g., African meningitis belt) or exposure to overcrowded situations, (e.g., Hajj pilgrimage) may be at increased risk of meningococcal disease(1).

Reference

1. World Health Organisation, Meningococcal vaccines: Polysaccharide and polysaccharide conjugate vaccines. WHO position paper. Weekly Epidemiological Record. 2002;77331-39