- FDA approves Arexvy for adults 18-49 at risk for RSV-related LRTD.
- 21 million US adults under 50 have risk factors for severe RSV.
- Annual RSV burden: 17,000 hospitalizations, 277,000 ER visits, 1.97 million outpatient visits.
- Phase IIIb trial shows non-inferior immune response compared to adults 60+.
FDA Approval
The US FDA has expanded the age indication for GSK's Arexvy vaccine to include adults aged 18 to 49 who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Previously, the vaccine was approved for adults aged 60 and older, and those aged 50-59 at increased risk.
RSV Impact
In the US, approximately 21 million adults under 50 have at least one risk factor for severe RSV infection. The annual burden of RSV among adults aged 18-49 includes about 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits. Most hospitalizations occur in younger adults with chronic medical conditions like cardiopulmonary, kidney, or renal disease, obesity, and diabetes.
Clinical Trials
The FDA's decision was based on data from a Phase IIIb trial demonstrating a non-inferior immune response compared to adults aged 60 and above. Vaccine efficacy was previously demonstrated in an earlier Phase III trial. The safety profile was consistent with findings from the broader Phase III program, with common adverse events including injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.
Future Plans
GSK is advancing regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives.
