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# GSK’s Arexvy Gets Expanded Approval
- URL: https://www.fdaweb.com/gsks-arexvy-gets-expanded-approval/
- Published: 2024-06-10T12:00:00.000Z
- Updated: 2026-09-14T14:32:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157146

FDA has approved an expanded use for GSK’s Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 years and who are at increased risk. The vaccine was previously approved for use in adults aged 60 and older.

Approval was based on data from a Phase 3 trial \[NCT05590403\] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions. “The trial’s primary endpoints were RSV-A and RSV-B neutralization titres of both groups at one month after the vaccine administration compared to adults aged 60 and older,” GSK says.

Safety and reactogenicity data were consistent with results from earlier trials, according to the company. Common reported adverse events were injection site pain, myalgia, fatigue and headache, which it says were mostly transient and mild to moderate in intensity.