GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency for the prevention of RSV disease in adults aged 50-59 at increased risk

GSK plc announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If accepted, GSK’s RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in Europe in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

This regulatory submission follows the positive results from a phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions.

The burden of RSV disease in adults is likely to be underestimated due to lack of awareness, lack of standardised testing, and under-detection in surveillance studies. People with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure and diabetes are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death. The burden in adults aged 50-59 and at increased risk for RSV disease is similar to that of 60 and above.

GSK is the first company to file for regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease due to underlying medical conditions. A European regulatory decision is anticipated in H2 2024.