GSK vaccine Arexvy accepted for regulatory review by EMA for adults aged 50-59 at increased risk for RSV
London: GSK plc has announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If accepted, GSK’s RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in Europe in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
This regulatory submission follows the positive results from a phase III trial [NCT05590403] 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.
The burden of RSV disease in adults is likely to be underestimated due to lack of awareness, 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 burden in adults aged 50-59 and at increased risk for RSV disease is similar to that of 60 and above.
GSK is the first company to file for regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease due to underlying medical conditions. A European regulatory decision is anticipated in H2 2024.
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 European Medicines Agency 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 lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older in the US, 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.
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