By Connor Hart
GSK said the Food and Drug Administration expanded the approved age indication of its RSV vaccine to adults between the ages of 18 and 49 with increased risk of lower respiratory tract disease.
The vaccine, Arexvy, had previously been approved in the U.S. to help prevent RSV-related lower respiratory tract disease in adults older than 60, and adults between the ages of 50 and 59 with increased risk.
The U.K. pharmaceutical company said Friday that the decision to expand the approved age indication is supported by late-stage trial results, in which the vaccine demonstrated a non-inferior immune response for the cohort, compared with adults over the age of 60.
Arexvy's safety profile for the 18- to 49-year-old cohort was consistent with findings from the broader program that supported the initial U.S. approval, GSK said. The company added it continues to advance regulatory submissions for the vaccine across multiple geographies, aiming to expand availability and support long-term growth objectives.
"This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system," said Sanjay Gurunathan, head of vaccines and infectious diseases research and development.
GSK estimates that 21 million adults under the age of 50 in the U.S. have at least one risk factor for severe RSV infection. RSV is a common contagious virus that affects the lungs and breathing passages, impacting an estimated 64 million people of all ages globally every year.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
03-13-26 0900ET
