GSK’s Arexvy vaccine approved by FDA for RSV prevention in adult patients

Betsy Goodfellow | June 10, 2024 | News story | Medical Communications |  FDA, GSK, Immunology, Vaccine 

GSK has announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV in adults from 50 to 59 years of age. The vaccine is already approved for adults over the age of 60.

The approval was based on positive results from a phase 3 trial which assessed the vaccine’s immune response and safety in adults 50-59, including those at an increased risk of RSV lower respiratory tract disease (LRTD) due to underlying medical conditions.

The company has also filed regulatory submissions to extend the use of its vaccine in adults of this age group in Europe, Japan and other areas, where the regulatory submissions are still undergoing review.

The company’s trials assessing the vaccine’s benefit in patients aged 18-49 at increased risk and immunocompromised adults over the age of 18 are underway, with results expected in the second half of 2024.

Tony Wood, chief scientific officer at GSK, commented: “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.”   

Betsy Goodfellow