GSK receives positive opinion in Europe from the CHMP for Nimenrix®
Posted: 17 February 2012 | | No comments yet
The EMA’s CHMP has issued a positive opinion recommending marketing authorisation for Nimenrix® (MenACWY-TT)…
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”.
About Nimenrix® –
Nimenrix® is a candidate conjugate vaccine 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.
About Neisseria meningitidis –
Neisseria meningitidis is a highly contagious disease and can be easily transmitted with potentially disabling and in severe cases, even potentially life-threatening consequences. While there are currently no reliable global prevalence figures a recent WHO report suggests that in the African meningitis belt, which is inhabited by around 300 million people, meningococcal disease can occasionally reach rates of up to 1000 cases per 100,000 populations during the dry season. Incidence in Europe and the Americas is approximately 0.2 – 14 cases per 100,000 population and 0.3 – 4 cases per 100,000 respectively1.
- WHO. Weekly epidemiological record, No 47, 2011, 86, 521-540