|
GSK PLC on Monday said the meningitis vaccine Menveo has been approved by the US Food & Drug Administration in a single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W.
GSK is a Brentford, London-based biopharmaceutical firm.
The company said the approval removes the need for reconstitution of Menveo before use in individuals between 10-55 years of age.
Invasive meningococcal disease, 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.
GSK said the Menveo one-vial presentation ‘now comes in a ready to use single vial giving healthcare providers a more convenient option’.
The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.
GSK Vaccines & Global Health President Roger Connor 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 approval came after GSK announced a vast decline in severe respiratory syncytial virus disease among people aged 60 years and older who were vaccinated with its RSV vaccine candidate last week.
Shares were up 0.8% at 1,360.60 pence each on Monday morning in London.
Copyright 2022 Alliance News Limited. All Rights Reserved.
|
