RSV Vaccine For Adults Aged 50-59 at Increased Risk Accepted in Europe for Regulatory Review

GSK plc announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) AREXVY™ vaccine to adults aged 50-59 who are at increased risk for RSV disease.

A European regulatory decision is anticipated in the second half of 2024.

If accepted, AREXVY would be the first vaccine available to help protect this population. 

GSK recently estimated that nearly 80 million adults in the U.S. could receive an RSV shot for the first time. 

GSK announced on November 1, 2023, that AREXVY's third-quarter 2023 sales were approximately $850 million. 

As of January 30, 2024, AREXVY is approved in Europe, Japan, the United States, and several other countries for adults aged 60 and over to prevent lower respiratory tract disease caused by RSV.