FDA Approves GSK's Arexvy, World's First RSV Vaccine For Older Adults

(RTTNews) - The U.S. Food and Drug Administration approved GSK Plc.'s (GSK.L, GSK) Arexvy, the world's first respiratory syncytial virus or RSV vaccine for older adults.

Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease.

GSK said that, in June 2023, the Advisory Committee on Immunization Practices will make recommendations on the appropriate use of the vaccine in the US.

The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.

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