GSK Single-Vial Meningitis Treatment Approved by U.S. FDA

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 [e-mail]

(END) Dow Jones Newswires

October 17, 2022 02:39 ET (06:39 GMT)

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