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JUNE 13, 2024

FDA Grants Expanded Indication for GSK’s Arexvy


Originally published by our sister publication Infectious Disease Special Edition

The FDA granted a new indication for GSK’s Arexvy adjuvanted respiratory syncytial virus vaccine to prevent RSV-related lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk for RSV. 

The RSV vaccine contains recombinant RSV glycoprotein F stabilized in the pre-fusion conformation (RSVPreF3).

The agency reviewed positive results from a phase 3 trial