GSK Receives FDA Approval for World-First RSV Vaccine

GSK plc (NYSE: GSK) has received FDA approval for AREXVY for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.

The ground-breaking approval enables older adults to be protected from RSV disease for the first time.

The US launch of AREXVY is planned before the 2023/24 RSV season and GSK intends to progress regulatory review in other countries as quickly as possible.

Highlights

The FDA’s decision is based on data from the positive pivotal AReSVi-006 Phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease.

The trial showed that efficacy against severe RSV-LRTD was 94.1%.

GSK has initiated a clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50-59, including participants with underlying comorbidities.  This trial is fully recruited and results are expected in 2023.

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. 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.