Pharmaceutical Executive June 10, 2024
Don Tracy, Associate Editor

Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.

GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through...

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Topics: Biotechnology, FDA, Govt Agencies, Healthcare System, Patient / Consumer, Pharma / Biotech, Provider, Public Health / COVID
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