GSK’s Arexvy has become the first respiratory syncytial virus (RSV) vaccine to be approved by the European Commission (EC) for use in adults aged 50 to 59 years who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD).
The EU regulator’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and comes just over a year after it approved Arexvy for use in adults aged 60 years and older.
RSV is a common respiratory virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, an estimated 20 million adults aged 50 to 59 years in the EU have a medical condition that increases their risk of severe RSV outcomes.
The virus can worsen conditions including chronic obstructive pulmonary disease, asthma and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalisation and death.
GSK’s Arexvy contains a protein from the surface of the RSV virus and teaches the immune system how to defend itself against disease.
The EC’s latest approval was supported by positive results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at an increased risk for RSV-LRTD due to underlying medical conditions.
Tony Wood, chief scientific officer at GSK, said: “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 was recently approved by the US Food and Drug Administration for higher-risk adults aged 50 to 59 years, and GSK has filed regulatory submissions to extend the use of the vaccine to this population in other markets.
The company is also evaluating the vaccine in younger groups, including in higher-risk adults aged 18 to 49 years and in immunocompromised adults aged 18 and over, with readouts for these trials expected later this year.