The US Food and Drug Administration (FDA) has accepted GSK’s application for priority review for extended use of its respiratory syncytial virus (RSV) vaccine Arexvy in adults ages 50 to 59 at higher risk for complications.

In a press release today, GSK said its application is supported by promising results from a phase 3 trial in the age-group. Arexvy is currently approved for use in adults ages 60 and older. GSK added that if approved, Arexvy would be the first RSV vaccine recommended for use in people in their fifties. The FDA expects to make a decision by June 7, 2024.

Drug regulators in the European Union and Japan are also reviewing GSK’s applications for use in people ages 50 to 59 at higher risk for RSV.