USFDA accepts under priority review GSK application to extend indication of adjuvanted RSV vaccine
London: GSK plc has 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 is currently approved in the US in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.
The application is supported by positive results from a phase III trial evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions. GSK used a Priority Review Voucher to reduce the US FDA review period of a supplemental Biologics License Application (sBLA) by four months. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is 7 June 2024.
The burden of RSV disease in adults is likely to be underestimated due to lack of awareness, a lack of standardised testing, and under-detection in surveillance studies. People with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure and diabetes, are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.
The FDA has approved GSK’s RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in Europe, Japan, UK, Canada and several other countries. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.
