GSK RSV vaccine Arexvy accepted for regulatory review by EMA to expand use in adults 18 years, older
London: GSK plc has 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 include adults from 18 years of age.
As per the company, Arexvy was the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk for RSV disease.
RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year. RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.
A European regulatory decision on this submission is anticipated in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.
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