GSK's RSV Vaccine Awaits FDA Approval for Expanded Use

GlaxoSmithKline's (GSK) RSV vaccine, Arexvy, is under review by the US FDA for expanded use to include adults aged 18 to 49. The vaccine is currently approved for use in adults aged 60 and older. The expansion aims to provide protection against respiratory syncytial virus (RSV) in a broader age group.

GlaxoSmithKline (GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy, the company's respiratory syncytial virus (RSV) vaccine, to adults aged 18-49 who are at increased risk. Currently, Arexvy 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.

The regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above. The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US. A regulatory decision by the FDA on this submission is expected in H1 2026.

According to the Centers for Disease Control and Prevention (CDC), 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, with an estimated 21 million of these people having 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).

This expansion aims to provide protection against RSV in a broader age group, addressing a significant public health concern. GSK is also seeking expanded indications for its RSV vaccine in other geographies, including in the European Economic Area and Japan.

References:
[1] https://www.directorstalkinterviews.com/gsk-s-arexvy-fda-review-accepted-for-adults-18-49-at-increased-risk/4121207312
[2] https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.html