USFDA nod to GSK Menveo in new single-vial presentation to prevent invasive meningococcal disease

Invasive meningococcal disease (IMD), known as meningitis, is an uncommon but serious illness that can cause life-threatening complications or even death. IMD is caused by Neisseria meningitidis, with the majority of cases caused by serogroups (A, B, C, W, Y) in most of the world. Among those who contract meningitis, one in ten will die, despite treatment, sometimes in as little as 24 hours. One in five (up to 20%) of meningitis survivors suffer long-term consequences, such as brain damage, amputations, hearing loss, and nervous system problems.

Roger Connor, President, Vaccines and Global Health, GSK, said: "Outbreaks of this dangerous disease continue to occur, impacting families, health systems, and society. This FDA approval of Menveo one-vial presentation offers greater convenience to healthcare providers to help prevent this disease in at-risk populations in the United States."

The original two-vial presentation of Menveo requiring reconstitution was approved by the FDA in 2010 and remains available for use in individuals from two months to 55 years of age.

The Menveo vaccine (supplied in a two-vial presentation) for meningococcal groups A, C, Y, and W has been approved in over 60 countries, with more than 72 million doses distributed worldwide since 2010. Menveo does not prevent Neisseria meningitidis serogroup B infections.