GSK’s RSV vaccine Arexvy approved by FDA for use in adults aged 50 to 59 years

10 Jun 2024
pmlive.com
Drug ApprovalVaccine
GSK’s RSV vaccine Arexvy approved by FDA for use in adults aged 50 to 59 years
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Source: PMLiVE
GSK’s Arexvy has become the first respiratory syncytial virus (RSV) vaccine to be approved by the US Food and Drug Administration (FDA) for use in adults aged 50 to 59 who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD).
The regulator’s decision comes just over a year after it approved Arexvy for use in adults aged 60 years and older.
RSV is a common contagious virus affecting the lungs and breathing passages. Although most people can recover within a week or two, 13 million adults aged 50 to 59 years in the US have a medical condition that increases their risk of severe RSV outcomes.
The virus can worsen conditions including chronic obstructive pulmonary disease, asthma and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalisation and death.
GSK’s Arexvy contains a protein from the surface of the RSV virus and teaches the immune system how to defend itself against disease.
The FDA’s latest approval was supported by positive results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at an increased risk for RSV-LRTD due to underlying medical conditions.
Tony Wood, GSK’s chief scientific officer, said the decision “reflects the importance of broadening the benefits of RSV immunisation” to this patient population.
“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,” he said.
Beyond the US, Arexvy is approved to prevent RSV-LRTD in adults aged 60 years and older in over 40 countries. GSK has also filed regulatory submissions to extend the use of the vaccine to higher-risk adults aged 50 to 59 in Europe and other markets.
Professor Ann Falsey, University of Rochester School of Medicine, said: “When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider.
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