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US FDA to review GSK bid to extend use of respiratory virus drug
(Sharecast News) - GSK said the US Food and Drug Administration has accepted an application for review to extend the indication of its Arexvy respiratory syncytial virus vaccine to adults aged 18-49 who are at increased risk.
The vaccine is approved in the US for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk. A regulatory decision by the FDA on this submission is expected in the first half of 2026.
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.
More than 125 million adults in the US are under 50 years of age and an estimated 21 million of these have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure and coronary heart disease.
GSK added that it was still seeking expanded indications for the vaccine in other regions including in the European Economic Area and Japan.
Reporting by Frank Prenesti for Sharecast.com
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