A Shot of Success: GSK's Arexvy Wins FDA Approval, Pioneering RSV Prevention for Older Adults in Multi-Billion Dollar Market

The FDA has approved GSK Plc's GSK Arexvy (respiratory syncytial virus vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. 

This is the first RSV vaccine for older adults to be approved worldwide.

RSV is a common, contagious virus that can lead to potentially serious respiratory illness. It causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in the US in adults aged 65 years and older each year.

The approval is based on GSK's pivotal AReSVi-006 phase 3 trial data. 

In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults 60 years and older, meeting the primary endpoint.

In addition, efficacy was 94.6% in older adults with at least one underlying medical condition. Efficacy against severe RSV-LRTD was 94.1%.

In March, FDA's adcomm voted 7 to 4 on safety and 7 to 4 on effectiveness, favoring Pfizer Inc's PFE RSV bivalent vaccine candidate.

Pfizer and GSK are running a tight race to tap into the RSV vaccine market. Analysts say the market is estimated to be over $5 billion and could exceed $10 billion by 2030.

Price Action: GSK shares are up 1.48% at $38.88 on the last check Wednesday.