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EMA approval on Arexvy for 50-59 at risk
EMA approval on Arexvy for 50-59 at risk.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 29 August 2024, London UK\n \nEuropean Commission approves expanded age indication for GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk\n \n· An estimated 20 million adults aged 50-59 in 30 European countries* have a medical condition that increases their risk for RSV disease1-3\n· Authorisation helps protect this population for the first time ahead of this RSV season\n· This follows approval in US, with other countries anticipated, including Japan later this year\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. Since June 2023, GSK's RSV vaccine has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD4.\n \nAdults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions5,6. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.6\n \nIt is estimated that there are about 65 million adults aged between 50 and 59 in the European Union/European Economic Area1, with an estimated 20 million of these people (one-third) having at least one underlying medical condition that puts them at increased risk for RSV disease.2,3\nTony Wood, Chief Scientific Officer, GSK, said: \"Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.\"\nThe regulatory application was 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,...