GSK Shingrix new prefilled syringe presentation accepted for review by USFDA
GSK plc has announced that the US Food and Drug Administration (USFDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).
The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for pharmacists, physicians and other healthcare professionals who administer vaccinations. 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 presentation has the same composition as the reconstituted vaccine and 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; and 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.
Shingles is a painful, blistering rash that can last for weeks. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not everyone will develop shingles. An estimated one million people develop shingles annually in the US.
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. By age 50, VZV is present in most adults and may reactivate with advancing age. As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.
Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of 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 that contributes to the challenge of protecting adults aged 50 and over from shingles. 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. The use of RZV should be in accordance with official recommendations and local product label.
The following information is based on the US Prescribing Information (PI) for Shingrix.
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