GSK's Nimenrix gets green light in Europe
GlaxoSmithKline's ($GSK) meningitis vaccine Nimenrix has been granted approval in Europe by the Committee for Medicinal Products for Human Use (CHMP). This follows the CHMP's recommendation for approval in February, when it said it "considers there to be a favorable benefit-to-risk balance for Nimenrix and therefore recommends the granting of the marketing authorization."
The groups most at risk from meningitis are children under age 5 and teenagers, and a single shot of Nimenrix will give protection against four of the 6 epidemic-causing subtypes of Neisseria meningitidis. According to the company, this is the first quadrivalent conjugate meningitis vaccine to be approved in Europe for use from 12 months of age.
A GSK spokesperson told PharmaTimes that the company is expecting the vaccine to be "incorporated into child immunization programs in those European countries where local guidelines recommend vaccination to help protect against meningitis, as well as being used through private access in markets where there are no universal mass immunization programs."
Neisseria meningitidis affects up to 1 in 100 in Africa, and the GSK spokesperson confirmed to PharmaTimes that the company would make the vaccine available in developing countries using a tiered pricing system.
GSK is awaiting approval for MenHibrix, a vaccine that combines protection against Neisseria meningitidis and Haemophilus influenzae B. The FDA asked for further information in June 2010 and September 2011, and GSK announced that it had submitted this in December.