US FDA Expands Age Indication for GSK’s AREXVY RSV Vaccine to Adults 50-59 at Increased Risk

GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 to 59 who are at increased risk. This approval expands the vaccine’s use, as it was already authorized for individuals aged 60 and older, recommended by CDC/ACIP using shared clinical decision-making.

RSV is a significant health concern, particularly for adults with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes. These conditions heighten the risk of severe outcomes from RSV, including pneumonia, hospitalization, or death. A systematic review in the US estimated that RSV causes approximately 42,000 hospitalizations annually in adults aged 50-64.

Tony Wood, Chief Scientific Officer at GSK, emphasized the importance of expanding RSV immunization benefits to adults aged 50-59 with increased risk. He stated, “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.”

The FDA's decision was based on positive results from a phase III trial (NCT05590403), which evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those with underlying medical conditions increasing their risk for RSV-LRTD. Professor Ann R. Falsey of the University of Rochester School of Medicine expressed her approval, noting the significance of having a vaccine that can protect adults in this age group with underlying health issues from severe RSV-related illness.

GSK has also sought regulatory approval to extend the vaccine’s use to adults aged 50-59 at increased risk in Europe, Japan, and other regions. Ongoing trials are assessing the vaccine’s safety and immunogenicity in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and older, with data expected in the second half of 2024.

AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and GSK’s proprietary AS01E adjuvant. It was initially approved by the FDA in May 2023 for preventing RSV-LRTD in individuals aged 60 and older. The vaccine has also received approval for this use in over 40 countries, including Europe and Japan. Regulatory reviews are ongoing globally, and the proposed trade name awaits regulatory approval in other markets.

The phase III trial (NCT05590403) was a placebo-controlled, observer-blind study conducted across multiple countries. It aimed to evaluate the immune response and safety in participants aged 50 to 59, both with and without pre-defined chronic diseases, compared to adults aged 60 and older. Primary endpoints included RSV-A and RSV-B neutralization titers one month post-vaccination. Safety data were consistent with earlier findings, with common adverse events including injection site pain, myalgia, fatigue, and headache, which were generally transient and mild to moderate.

RSV is a prevalent virus affecting the lungs and breathing passages, posing a higher risk to adults with comorbidities, compromised immune systems, or advanced age. It can exacerbate conditions like COPD, asthma, and chronic heart failure, leading to severe outcomes such as pneumonia, hospitalization, and death. In the US, RSV is estimated to cause around 177,000 hospitalizations annually in adults 65 and older and 42,000 in adults aged 50-64.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!