Arexvy approved in US for expanded age indication in adults aged 18–49 years at increased risk

GSK has recently announced that the US FDAV has expanded the approved age indication of Arexvy to adults aged 18 to 49 years at increased risk for lower respiratory tract disease caused by RSV. GSK’s RSV vaccine was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine 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.”

In addition the annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalisations, 277,000 emergency department admissions, and 1.97 million outpatient visits. Most hospitalisations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease.

Note that the FDA’s decision was supported by data from a Phase IIIb trial demonstrating a non-inferior immune response compared to adults aged 60 years and above. Vaccine efficacy was demonstrated in the earlier Phase III trial. The safety profile was consistent with findings from the broader Phase III programme that supported the initial US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.

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arexvy, GSK’s RSV vaccine