GSK snags first RSV vax approval

May 4, 2023

GSK announced this week that the FDA has approved its RSV jab — to be sold as Arexvy — for preventing lower respiratory tract disease (LRTD) in individuals 60 years of age and older, marking the first-ever RSV vaccine for older adults to be approved globally.

The respiratory syncytial virus is a commonly found virus that can cause potentially serious respiratory illness. Older adults, particularly those with underlying medical conditions such as chronic heart and lung disease, as well as diabetes, are at higher risk of experiencing severe RSV illness and are responsible for most RSV hospitalizations. In adults aged 65 years and older, it results in approximately 177,000 hospitalizations and an estimated 14,000 deaths annually in the United States.

Last November, GSK snagged Priority Review designation for its BLA with support from positive data from the pivotal AReSVi-006 phase 3 trial, which showed high overall vaccine efficacy against RSV LRTD in adults aged 60 years and older. In early March, an FDA advisory panel voted unanimously 12-0 on the vaccine's effectiveness and 10-2 on safety, teeing the candidate up for its May approval.

In what has been a heated race for approval, Pfizer is also awaiting a U.S decision this month. Back in December, the drugmaker announced that it had received Priority Review for its vax candidate, RSVpreF, which had also been granted Breakthrough Therapy designation earlier last year. The designation shortened the review period by four months, granting RSVpreF a May 31 PDUFA date.