2. May 2012 15:02
The European Commission has approved GSK’s vaccine Nimenrix for treatment of meningitis in young children.
The vaccine offers protection against a highly contagious strain of meningitis to which children in the first four years of life are particularly susceptible.
Nimenrix is the first form of immunisation against invasive meningococcal disease to have EU approval for use in children as young as 12 months.
Given in a single dose, Nimenrix protects against Neisseria meningitidis serogroups A, C, W-135 and Y, which can cause deafness, epilepsy and death.
According to the WHO, this strain of meningitis uniquely has the potential to cause major epidemics: the bacteria, carried in the throat, are spread by coughing and can invade the brain.
Sanofi Pasteur’s Menactra offers protection against the same strand and is approved for use in infants in the US, but is not available in Europe; while Novartis’ Menveo is only approved for people aged 11 years and above in Europe.
Thomas Breuer, 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.”
24. February 2012 13:00
The European Medicines Agency (EMA) has recommended Nimenrix from GlaxoSmithKline (GSK) for active immunisation against a form of meningitis that is prevalent in Africa.
Nimenrix (MenACWY-TT) is a candidate conjugate vaccine against invasive meningococcal disease caused by the Neisseria meningitidis virus.
The positive recommendation improves the global prospect of controlling a highly contagious, disabling and sometimes fatal disease.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed 17 clinical studies from 17 countries, covering immunogenicity and safety data from more than 8,000 patients.
According to a recent WHO report, meningococcal disease can affect as many as one person in ten in a region of Africa that contains 300 million people. It is relatively rare in Europe, with incidence reaching 140 cases per million people.
Thomas Breuer, Senior VP and Head of Global Vaccine Development at GSK, said: GSK has over 20 years’ experience in developing meningococcal vaccines. This positive opinion represents a major milestone in our development programme.”
GSK’s vaccines business, GSK Biologicals, has over 30 vaccines currently approved for marketing and 20 more in development.