GSK plc (LSE/NYSE:GSK) (LSE/NYSE: GSK) said in an announcement the US Food and Drug Administration has expanded the approved age indication of Arexvy (Respiratory Syncytial Virus vaccine, [adjuvanted]) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV.
The vaccine was previously approved in the US for adults 60 years and older and for adults 50–59 at increased risk; the company said Arexvy is not for use in pregnant individuals. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: "This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations."
The company said an estimated 21.3 million US adults aged 20–49 have at least one risk factor for severe RSV disease, and that the annual RSV burden among US adults aged 18–49 is about 17,000 hospitalisations, 277,000 emergency department admissions and 1.97 million outpatient visits.
The FDA's decision was supported by data from a Phase IIIb immunogenicity trial (NCT06389487). The company said the open-label study enrolled 1,458 participants across 52 locations in six countries and demonstrated a non-inferior immune response in 18–49-year-olds compared with adults aged 60 and above; safety and reactogenicity were consistent with the broader Phase III programme, with the most common adverse events reported as injection site pain, fatigue, myalgia, headache and arthralgia.
Arexvy contains recombinant RSVPreF3 antigen combined with GSK's proprietary AS01E adjuvant. The company said the vaccine is approved for prevention of RSV-LRTD in individuals 60 and older in 70 countries, for adults 50–59 at increased risk in more than 60 countries, and in the European Economic Area for adults aged 18 years and older.
The recap
• FDA expanded Arexvy to include adults aged 18–49 years at increased risk for RSV-related LRTD. • The company estimates about 21.3 million US adults 20–49 have at least one risk factor for severe RSV disease. • Phase IIIb trial NCT06389487 (n=1,458) showed a non-inferior immune response versus adults aged 60 and above.
