The FDA Has Accepted Under Priority Review GSK's Application To Extend The Indication Of Its Adjuvanted Respiratory Syncytial Virus Vaccine To Adults Aged 50-59 Who Are At Increased Risk For Respiratory Syncytial Virus Disease
Portfolio Pulse from Benzinga Newsdesk
The FDA has accepted GSK's application for priority review to extend the use of its Arexvy RSV vaccine to adults aged 50-59. Currently, Arexvy is approved in the US for adults aged 60 and over to prevent lower respiratory tract disease caused by RSV. If approved, it would be the first vaccine for this age group.
February 06, 2024 | 8:41 am
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GSK's Arexvy RSV vaccine is under FDA priority review to extend its use to adults aged 50-59, potentially expanding its market.
The FDA's acceptance of GSK's application for priority review to extend the indication of its Arexvy RSV vaccine to a younger demographic (50-59) could significantly expand the vaccine's market and usage. Given the current approval for adults 60 and over, this expansion would make Arexvy the first RSV vaccine available for this new age group, potentially boosting GSK's market share and revenue in the vaccine segment.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100