FDA approves GSK’s Arexvy, an RSV vaccine for older adults

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GSK plc announced that the U.S. FDA has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. 

“Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year," said Tony Wood, GSK chief scientific officer. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

RSV is a common, contagious virus that can lead to potentially serious respiratory illness. It causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in the U.S. in adults aged 65 years and older each year. Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.

The U.S. FDA approval is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs 40 of 12,494) against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 vs 18 of 4,861) in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1% (95% CI, 62.4–99.9, 1 of 12,466 vs 17 of 12,494).

The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache and arthralgia. These were generally mild to moderate and transient.

In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the U.S. The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.


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