GSK's liquid meningitis vaccine, Menveo, received approval from the European Commission to be sold in the European Union.
The British pharmaceutical company said Wednesday that the fully liquid vaccine supports simplifying the vaccination process against invasive meningococcal disease, or IMD, as it offers healthcare providers an option that doesn't require reconstitution before its use.
The approval means the single-vial treatment is now licensed for active immunization of children from the age of two, adolescents and adults.
GSK's submission to the European Commission was based on two positive Phase 2b trials. These types of trials--often called mini-phase three--determine how well a drug works in subjects at a given dose to assess their efficacy.
The original presentation of Menveo that requires reconstitution, which was approved by the European Medicines Agency in 2010, is unaffected by this marketing authorization, the company said.
Write to Christian Moess Laursen at [email protected]