Nimenrix was granted marketing authorization for immunization against meningitis caused by bacteria called Neisseria meningitidis. The vaccine protects against four of the six types of the bacterium.
Infants and toddlers up 4-years-old are at greatest risk of developing meningitis from this bacteria. The contagious disease can lead to deafness, epilepsy and neurological disorders. Severe cases can be fatal.
Britain-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has also sought U.S. approval for meningitis vaccine candidate MenHibrix, a product that would combine a GSK vaccine for certain forms of meningits with another GSK vaccine that protects against Haemophilus influenzae type b, or Hib. But GSK has received two complete response letters on the vaccine candidate, in 2009 and in 2010. GSK did not disclose specific FDA concerns about the MenHibrix application. Last December, GSK submitted to the FDA additional information to support the application for MenHibrix approval.
The Centers for Disease Control and Prevention estimates that between 1,000 and 3,000 cases of meningococcal disease are reported each year in the United States.