GSK Single-Vial Meningitis Treatment Approved by U.S. FDA
October 17 2022 - 2:54AM
Dow Jones News
By Joe Hoppe
GSK PLC said Monday that the U.S. Food and Drug Administration
has approved the single-vial presentation of its Menveo product to
treat meningitis.
The pharmaceutical giant said the new, ready-to-use single-vial
presentation--used to help prevent disease caused by meningococcal
bacteria serogroups A, C, Y and W--removes the need for
reconstitution of Menveo before use in individuals ages 10 through
55, giving healthcare providers a more convenient option.
The single-use presentation will be available to U.S. federal
customers initially, with broader availability expected in
mid-2023, the company said.
The original two-vial presentation, which requires
reconstitution, was approved by the FDA in 2010 and remains
available for individuals from 2 months to 55 years old.
"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," Roger Connor, president of
vaccines and global health at GSK, said.
Invasive meningococcal disease, known as meningitis, is an
uncommon but serious illness that can cause life-threatening
complications or death.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
October 17, 2022 02:39 ET (06:39 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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