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6-K: Gsk's Shingrix New Prefilled Syringe Presentation Accepted for Review by European Medicines Agency

SEC ·  Jan 27 12:29

Summary by Futu AI

GSK announced that the European Medicines Agency has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix vaccine for shingles prevention. The new presentation eliminates the need to reconstitute separate vials before administration, offering healthcare professionals a more convenient option. This follows the US FDA's acceptance of the file on January 8, 2025.The vaccine maintains identical composition to the current version, which consists of a lyophilised antigen and liquid adjuvant. Shingrix has been approved in the EU since 2018 for adults aged 50 and older, and since 2020 for adults 18 and older at increased risk of herpes zoster. Over 25 million Europeans have received the vaccine since its launch.Shingles, affecting up to 1 in 3 adults in their lifetime, typically presents as a painful rash and can lead to post-herpetic neuralgia in up to 30% of cases. The condition significantly impacts work productivity, with 57% of affected individuals missing an average of 9.1 workdays.
GSK announced that the European Medicines Agency has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix vaccine for shingles prevention. The new presentation eliminates the need to reconstitute separate vials before administration, offering healthcare professionals a more convenient option. This follows the US FDA's acceptance of the file on January 8, 2025.The vaccine maintains identical composition to the current version, which consists of a lyophilised antigen and liquid adjuvant. Shingrix has been approved in the EU since 2018 for adults aged 50 and older, and since 2020 for adults 18 and older at increased risk of herpes zoster. Over 25 million Europeans have received the vaccine since its launch.Shingles, affecting up to 1 in 3 adults in their lifetime, typically presents as a painful rash and can lead to post-herpetic neuralgia in up to 30% of cases. The condition significantly impacts work productivity, with 57% of affected individuals missing an average of 9.1 workdays.

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