Label Expanded in Adults Aged 50-59 for Use of GSK’s Arexvy

Patients with high-risk respiratory syncytial virus (RSV) under the age of 60 are now able to take GSK’s AREXVY’s vaccine for the prevention of RSV lower respiratory tract disease (LRTD).

The FDA approved the expanded age indication for the RSV drug to ages 50 to 59 this past Friday, after initially being approved in the U.S. in May 2023 for RSV patients ages 60 and older.

AREXVY is now the first RSV vaccine for high-risk adults ages 50 to 59, according to a news release by GSK.

Research has revealed that a single dose of the GSK RSV vaccine reduced symptomatic RSV-LRTD in adults 60 and older by 82.6% during the first RSV season after vaccination compared to those who didn’t receive AREXVY, and by 56.1% during the second RSV season.

A review of U.S. studies estimated that RSV causes 42,000 hospitalizations annually in adults aged 50 to 64, especially those with underlying conditions like COPD, asthma, heart failure and diabetes, who are at higher risk for severe RSV complications, including pneumonia, hospitalization or death.

The approval of the GSK RSV vaccine was supported by results of a phase 3 trial in specific that evaluated its immune response and safety in adults aged 50 to 59.

The trial included participants who were high-risk for RSV-LRTD due to conditions such as chronic pulmonary and cardiovascular diseases, types 1 and 2 diabetes, chronic kidney disease and chronic liver disease.

The study confirmed the vaccine's efficacy and safety in these high-risk patients.

Ann R. Falsey, a professor at the University of Rochester School of Medicine, said in the release that “age is just a number,” but not the only factor to consider when it comes to the risks associated with RSV.

“Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions,” Falsey added. “Now there is a vaccine approved that can help protect them.”

GSK also filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50 to 59 at high-risk in Europe, Japan and other regions with decisions currently under review.

Trials reviewing the efficacy and safety of the vaccine in high-risk adults aged 18 to 49 and immunocompromised adults aged 18 and over are also underway and expected to reveal results in the second half of this year, according to GSK.