GlaxoSmithKline (GSK) has announced that Arexvy, its respiratory syncytial virus (RSV) vaccine, has received expanded approval from the European Commission (EC) for use in adults aged 18 and over.
Arexvy was previously approved for use in adults aged 60 and older, as well as adults aged 50 to 59 who presented an increased risk for RSV. It was the first RSV vaccine to receive authorisation in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
RSV is a virus that impacts the lungs and breathing passages. It is contagious and affects around 64 million people around the world annually. Chronic conditions, advanced age or immunocompromised status can increase the risk of getting RSV. Additionally, RSV can make many chronic conditions worse, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure. Serious cases of RSV can cause pneumonia, hospitalisation and death.
On average, 158,000 adults over the age of 18 are hospitalised for RSV infections annually in the EU. Adults hospitalised for RSV run a higher risk of severe complications and fatality than children. They also need more expensive treatments, placing a financial burden on healthcare systems. A lack of routine testing for RSV means that there are likely more annual cases than are identified.
Arexvy has already received approval for the prevention of RSV-caused LRTD in adults over 60 in more than 65 countries around the world. It is approved for use in high-risk individuals between 50 and 59 in more than 60 countries, including the US and Japan.
Sanjay Gurunathan, head of vaccines and infectious diseases R&D at GSK, 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.”