Therapy Areas: Vaccines
GSK receives FDA approval for world-first RSV vaccine for older adults
4 May 2023 -

Biopharma company GSK plc (LSE:GSK) (NYSE:GSK) announced on Wednesday that it has received US Food and Drug Administration (FDA) approval for Arexvy (respiratory syncytial virus vaccine, adjuvanted), the world's first respiratory syncytial virus (RSV) vaccine for older adults.

Arexvy was approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and over.

The vaccine was shown to have an efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint of the pivotal AReSVi-006 phase III trial. Efficacy against severe RSV-LRTD, which is defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1%.

Arexvy is expected to launch in the United States before the 2023/24 RSV season.

A final regulatory decision is anticipated in Europe in the coming months. Regulatory reviews are also ongoing in Japan and several other countries.