Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on expanding the use of Arexvy, its respiratory syncytial virus (RSV) vaccine, to adults aged 50-59 at increased risk of RSV disease. If approved, Arexvy would be the first RSV vaccine in the EU for this age group.

A decision on the EU marketing authorisation is expected by September 2024. Arexvy, a recombinant adjuvanted RSV vaccine, has been approved in Europe since June 2023 for adults aged 60 and over to prevent lower respiratory tract disease (LRTD) caused by RSV.

Adults with chronic conditions such as COPD, asthma, heart failure and diabetes are at higher risk for severe RSV complications, which can lead to pneumonia, hospitalisation or death. In Europe, RSV causes approximately 270,000 hospitalisations and 20,000 in-hospital deaths annually in adults aged 60 and older. The disease burden in adults aged 50-59 with similar risk factors is comparable to that of older adults.

The CHMP's positive opinion is based on a phase III trial evaluating the immune response and safety of the vaccine in adults aged 50-59, including those with underlying medical conditions. GSK's RSV vaccine received FDA approval for this age group on 7 June 2024 and is undergoing regulatory reviews in Japan and other countries.

GSK is focused on combining science, technology and talent to address diseases worldwide.