LONDON (dpa-AFX) - British drug major GSK plc (GSK, GSK.L) announced Thursday that the US Food and Drug Administration has approved a prefilled syringe presentation of Shingrix, GSK's Recombinant Zoster Vaccine or RZV, for the prevention of shingles or herpes zoster.
The company added that the prefilled syringe presentation of GSK's shingles vaccine is also undergoing regulatory review by the European Medicines Agency.
Consistent with the existing indications for Shingrix, the prefilled syringe presentation is licenced in the US for immunisation of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles.
The US Centers for Disease Control and Prevention or CDC recommends two doses of GSK's shingles vaccine to prevent shingles and related complications in adults aged 50 years or over, and two doses for adults aged 19 years or over who are or will be immunodeficient or immunosuppressed.
The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.
The existing vaccine presentation consists of two vials, a lyophilised (powder) antigen and a liquid adjuvant, which is required to be combined by the healthcare professionals prior to administering.
According to the firm, the new prefilled syringe simplifies the vaccine administration process as it removes the need to reconstitute separate vials prior to administration.
Brigid Groves, Vice President of Professional Affairs, American Pharmacists Association, said, 'The prefilled syringe presentation of GSK's shingles vaccine is good news, providing a convenient method of administration. The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.'
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