GSK’s Arexvy recieves approval for expanded age indication by The U.S FDA

GSK announces that the US FDA has approved Arexvy (which is a RSV vaccine) for the prevention of RSV lower respiratory tract disease in adults 50 through 59 years of age who are at increased risk. The vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making in the U.S.

A review of the studies have shown that RSV on average is estimated to cause 42,000 hospitalisations each year in adults aged 50-64 years old. Adults with underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.

Tony Wood, Chief Scientific Officer, GSK, said: “Today’s approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”  

Professor Ann R. Falsey, University of Rochester School of Medicine, said: “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider. Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them.” 

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Related Topics and Keywords

arexvy, GSK, rsv disease