GSK application for expanded RSV vaccine Arexvy use for adults 18-49 accepted for review by USFDA
London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk.
GSK’s RSV vaccine is approved in the US 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.
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. An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease (COPD), asthma, congestive heart failure and coronary heart disease (CHD). RSV can exacerbate certain medical conditions and can also lead to severe illness resulting in hospitalisation, and even death.
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