GSK's RSV Vaccine Arexvy Wins FDA Nod for High-Risk Younger Adults

Core Insights - GSK's RSV vaccine, Arexvy, received FDA approval for expanded use in adults aged 18 to 49 years at higher risk of lower respiratory tract disease (LRTD) [1][3] - Year-to-date, GSK's shares have increased by 8.8%, outperforming the industry growth of 2.7% [2] - The FDA's approval was based on late-stage study data showing Arexvy's immune response comparable to that of adults aged 60 and older, with a consistent safety profile [3] Regulatory Approvals - The European Commission approved Arexvy for all adults aged 18 years and older to prevent RSV-related LRTD, expanding from previous approvals for those aged 60 and older and high-risk individuals aged 50 to 59 years [4] - GSK's regulatory application for Arexvy in China for adults aged 60 years and above has been accepted, with a final decision expected in 2027 [5] Market Context - With the recent FDA approval, Arexvy becomes the third FDA-approved RSV vaccine for younger adults, alongside Pfizer's Abrysvo and Moderna's mResvia [6] - Pfizer's Abrysvo is also approved for pregnant individuals, making it unique in providing maternal immunization to protect infants against RSV [10] - Moderna's mResvia is approved for older adults aged 60 years and above and for high-risk adults aged 18 to 59 years [11] Sales Performance - Arexvy recorded global sales of £0.6 billion in 2025, reflecting a 2% increase at constant exchange rates, driven by growth in ex-U.S. markets despite declining sales in the U.S. due to slower uptake among the 60-plus population [12]