GSK’s RSV Vaccine, AREXVY, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk
GSK plc American Depositary Shares (Each representing two Ordinary Shares) (GSK)
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Source: Business Wire
Application supported by positive results of a phase III trial showing immune response and acceptable tolerability profile in this populationAdults aged 50 and above with underlying medical conditions are at increased risk for RSV disease1,2,3GSK is the first company to file for regulatory approval to extend RSV vaccination to adults aged 50-59 at increased riskUS FDA has set a Prescription Drug User Fee Act action date of June 7, 2024 PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If approved, GSK’s RSV vaccine would be the first vaccine available to help protect this population. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is currently approved in the US in adults aged 60 and over for the prevention o
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Sec Filings
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- GSK's page on the SEC website