GSK announces FDA expands approved age indication of Arexvy

GSK (GSK) plc announced that the U.S. Food and Drug Administration has expanded the approved age indication of Arexvy Respiratory Syncytial Virus vaccine to adults aged 18 to 49 years at increased risk for lower respiratory tract disease caused by RSV. GSK’s RSV vaccine was previously approved in the U.S. for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50-59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals, the company noted. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “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. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”