GSK’s RSV Shot Wins Expanded FDA Approval for At-Risk Adults Aged 50 to 59

GSK HQ_iStock, Wirestock

Pictured: GSK's office in Poznan, Poland/iStock, Wirestock

The FDA on Friday approved a label expansion for GSK’s respiratory syncytial virus vaccine Arexvy, allowing its use in adults aged 50 through 59 years who have a medical condition that increases their risk of severe outcomes.

In this younger patient age subgroup, Arexvy is indicated for the prevention of lower respiratory tract disease (LRTD) associated with respiratory syncytial virus (RSV). The vaccine can be used in patients with medical conditions that aggravate their risk of developing severe RSV disease.

Arexvy became the first FDA-approved RSV shot in May 2023, when it was authorized for use in older adults aged 60 years and older.

Friday’s label expansion was backed by data from a Phase III study that evaluated Arexvy’s immunogenicity and safety in the younger patient population. GSK posted early data from this study in October 2023, showing that Arexvy could trigger a non-inferior immune response.

GSK CSO Tony Wood in a statement said that the approval underscores the “importance” of making Arexvy more broadly accessible to older adults who are at increased risk. “For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD,” Wood said.

Arexvy’s use in the younger population is currently under review in Europe, Japan and other territories. The pharma is also evaluating the vaccine’s use in adults aged 18 to 49 years who are at a heightened risk of severe disease, as well as in immunocompromised patients aged 18 years and older. Readouts from these studies are expected in the second half of this year, according to GSK.

Friday’s label expansion will help GSK maintain its frontrunner position in the RSV vaccine race. Arexvy became the industry’s first FDA-approved RSV shot in May 2023, a month ahead of its main competitor, Pfizer’s Abrysvo.

In December 2023, GSK CEO Emma Walmsley said that the pharma is “delighted” with Arexvy’s market progress, adding that it expects the vaccine to make more than £1 billion in sales in its first commercial year. Arexvy “has lots of headroom for growth,” Walmsley said at the time.

In its first commercial quarter, Arexvy captured around two-thirds of retail vaccinations in the U.S. and generated nearly $859 million in sales. By comparison, Pfizer’s Abrysvo lagged far behind, bringing in only $375 million during the same quarter, less than half of Arexvy’s figures.

“If you look at our market share, I don’t think we performed as well as we thought or could, or we think we will going forward,” CFO David Denton told investors at a November 2023 event, according to Reuters.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Back to news