GSK Shares Rise After European Commission Approves Arexvy Label Expansion

GSK's (LON: GSK) shares are up around 0.7% on Thursday following the announcement that the European Commission has expanded the age indication for its RSV vaccine, Arexvy.

The vaccine is now approved for adults aged 50-59 at increased risk for respiratory syncytial virus (RSV) disease.

Previously approved for adults aged 60 and over, the company says the label expansion marks a significant step in protecting a broader population from the severe consequences of RSV infections.

According to GSK, an estimated 20 million adults aged 50-59 in 30 European countries have underlying medical conditions that increase their susceptibility to RSV disease.

RSV can lead to severe respiratory illnesses, such as pneumonia and bronchitis, particularly in older adults and those with weakened immune systems. The vaccine is said to offer a layer of protection, especially during the upcoming RSV season.

Tony Wood, Chief Scientific Officer at GSK, expressed his satisfaction with the approval, emphasising the importance of broadening access to RSV immunisation. “Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk,” he stated.

The regulatory approval for Arexvy is based on positive results from clinical trials that evaluated the vaccine's safety and effectiveness in adults aged 50-59. The vaccine has also been approved in the United States, with regulatory submissions pending in other countries, including Japan.