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The FDA has expanded the indication for the use of adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18-49 years at increased risk for lower respiratory tract disease (LRTD), according to a press release from manufacturer GSK.
The vaccine was previously approved in the US to prevent LRTD related to RSV infection in adults 60 years or older and high-risk adults aged 50-59 years but remains contraindicated for pregnant women of any age, according to the company.
The approval was supported by data from a phase 3b study in which the drug showed noninferiority in adults aged 18-49 years compared to those aged 60 years or older. The vaccine’s efficacy data that supported earlier approvals came from other phase 3 studies of adults aged 60 years or older. No new safety concerns were identified. The most common adverse events across studies to date include injection site pain, fatigue, myalgia, headache, and arthralgia within 4 days of vaccination, according to the company.
The vaccine is currently approved in 70 countries for the prevention of LRTD associated with RSV in individuals 60 years of age or older, and approved in more than 60 countries for high-risk adults aged 50-59 years with underlying medical conditions. The vaccine also is approved for adults aged 18 years or older in the European Economic Area, according to the company.
Full US prescribing information is available here.
The research was funded by GSK.
