USFDA nod to GSK Menveo in new single-vial presentation to prevent invasive meningococcal disease
"The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option," GSK stated.
London: GSK plc today announced that the US Food and Drug Administration (USFDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W.
"The Menveo one-vial presentation now comes in a ready to use single vial, giving healthcare providers a more convenient option," the company stated. The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.
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.
Read also: GSK gets CDSCO Panel nod to market anticancer Niraparib Tablet
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.