EC Approves GSK's Arexvy RSV Vaccine for Adults 50-59

GSK's Arexvy has achieved a significant milestone by becoming the first vaccine for respiratory syncytial virus (RSV) to receive approval from the European Commission (EC) for use in adults aged 50 to 59 years who are at greater risk of lower respiratory tract disease (LRTD) caused by RSV. This approval from the EU regulator follows a recent endorsement by the European Medicines Agency’s human medicines committee and comes a little over a year after Arexvy was approved for individuals aged 60 years and older.

RSV is a prevalent respiratory virus that manifests through several mild, cold-like symptoms. While most individuals recover within a week or two, around 20 million adults aged 50 to 59 years in the EU are considered at an elevated risk for severe RSV outcomes due to underlying medical conditions. These conditions, such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, can be exacerbated by RSV, potentially leading to severe consequences like pneumonia, hospitalization, and even death.

Arexvy, developed by GSK, contains a protein derived from the surface of the RSV virus, which trains the immune system to defend against the disease. The EC's recent approval was based on positive results from a late-stage clinical trial that assessed the immune response and safety of Arexvy in adults aged 50 to 59 years. This included those with an increased risk for RSV-LRTD due to pre-existing medical conditions.

Tony Wood, GSK's chief scientific officer, highlighted the significance of this development, stating: “RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.”

Arexvy's approval in Europe follows its recent approval by the US Food and Drug Administration (FDA) for higher-risk adults aged 50 to 59 years. GSK is also pursuing regulatory submissions to extend the vaccine's use to this demographic in other markets. Additionally, the company is investigating the vaccine's efficacy in younger age groups, including higher-risk adults aged 18 to 49 years and immunocompromised adults aged 18 and over, with trial results expected later this year.