GSK's Shingrix New Prefilled Syringe Presentation Accepted For Review By FDA

(RTTNews) - British drug maker GSK plc (GSK, GSK.L) announced Friday that the US Food and Drug Administration has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix, the Recombinant Zoster Vaccine or RZV, for the prevention of shingles or herpes zoster.

It is expected that the new presentation, if approved, will offer a convenient administration option to healthcare professionals. An FDA decision on the application is expected by June 20.

Shingles, a painful, blistering rash that can last for weeks, is caused by the reactivation of the varicella-zoster virus or VZV, the same virus that causes chickenpox. By age 50, VZV is present in most adults and may reactivate with advancing age.

Shingrix is a non-live, recombinant subunit vaccine indicated to prevent shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation.

The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for those who administer vaccinations.

The company noted that the new presentation has the same composition as the reconstituted vaccine. The submission is based on data demonstrating comparability between the two.

GSK's shingles vaccine has been approved in the US for the prevention of shingles in adults aged 50 years and older since 2017. It is also approved in adults 18 years and older, who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy, since 2021.

The company added that RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, RZV is also approved for adults aged 18 years or over at increased risk for shingles.

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