GSK Announces Expanded Indication of Arexvy for Lower Respiratory Tract Disease
Friday, August 30, 2024
GSK has announced that the European Commission has authorised the use of Arexvy, its respiratory syncytial virus (RSV) vaccine, for adults aged 50-59 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV.
RSV is a common virus that affects the lungs and respiratory system, particularly in older adults and those with underlying health conditions. These conditions include chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure, and diabetes, all of which can worsen due to RSV, potentially leading to severe outcomes such as pneumonia, hospitalisation, or death.
This follows the earlier approval of the vaccine for adults aged 60 and over across 50 countries, including Europe, Japan, and the United States.
Arexvy combines a stabilised recombinant RSV glycoprotein F antigen with GSK's proprietary AS01E adjuvant, designed to boost the immune response.
The recent approval for the 50-59 age group was based on positive results from a phase III trial, which evaluated the vaccine's immune response and safety in this population, particularly those with underlying medical conditions.
The significance of this approval, noting that expanding RSV immunisation to this younger at-risk group will help protect more people and ease the strain on healthcare systems, especially during the RSV season.
It is estimated that there are around 65 million adults aged 50-59 in the EU/EEA, with approximately 20 million of them having at least one underlying health condition that puts them at higher risk of severe RSV. GSK has also submitted regulatory applications to extend the vaccine's use to this age group in Japan and other regions, with further decisions expected soon.
Additionally, ongoing trials are assessing the vaccine's effectiveness in adults aged 18-49 who are at increased risk, as well as in immunocompromised adults aged 18 and over, with results anticipated later in 2024.
Source: gsk.com
