GSK PLC on Friday reported the US Food & Drug Administration has accepted its Shingrix vaccine syringe for review.
The Brentford, England-based pharmaceutical and biotechnology firm filed an application for a prefilled syringe of Shingrix, which has been approved in the US since 2017.
Shingrix is a recombinant zoster vaccine which helps prevent shingles, also known as herpes zoster. It is currently presented as an antigen powder and liquid adjuvant, which must be combined before dosing patients.
GSK said that a prefilled syringe will be more convenient for healthcare workers administering the vaccine.
‘The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two,’ GSK noted.
The company expects a decision from the FDA by June 20.
Shingrix in 2017 received US FDA approval to prevent shingles in adults aged 50 and older. Since 2021, it has been approved for use in immunocompromised patients aged 18 and up. GSK estimates around 90 million doses of the vaccine have been administered since its initial approval.
GSK shares were up 0.3% at 1,353.80 pence each on Friday morning in London.
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