GSK plc (LON:GSK, NYSE: GSK) has announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the European Commission* (EC) for use in adults aged 18 years and older. Arexvy was the first RSV vaccine authorised in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV. It was previously approved in adults aged 60 years and above, as well as in those aged 50 to 59 years who are at increased risk for RSV disease. Today’s updated indication now enables European countries to make the vaccine available to all adults aged 18 years and older.
Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalisation and even death, particularly for those with certain underlying health conditions. GSK is proud to expand prevention options against RSV across Europe.”
In the European Union, an average of 158,000 adults aged 18 and over are hospitalised due to RSV infections each year.1 Compared to children, adults hospitalised for RSV are at a higher risk of severe complications, require more costly treatments, have a higher fatality rate, and their true number is likely underestimated due to lack of routine testing.[2],[3],[4],[5]
GSK continues to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.
