Therapy Areas: Vaccines
GlaxoSmithKline Biologicals' Arexvy receives US FDA approval
4 May 2023 -

The United States Food and Drug Administration (US FDA) announced on Wednesday, that it has granted approval to GlaxoSmithKline Biologicals, a subsidiary of UK-based GSK plc, for its Arexvy, the first respiratory syncytial virus (RSV) vaccine, approved for use in the US.

Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The safety and effectiveness of Arexvy is based on the FDA's analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the US and internationally in individuals 60 years of age and older. The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination. Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA's analysis.

In this study, approximately 12,500 participants have received Arexvy and 12,500 participants have received a placebo.