GSK has announced that the European Medicines Agency (EMA) is currently reviewing its application to expand the approved use of its respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 18 and older.<\/p>\n
The move positions GSK to compete more effectively with other RSV vaccine makers, including Moderna\u2019s recently approved mRESVIA and Pfizer\u2019s Abrysvo. On Thursday, U.S. regulators authorised Moderna\u2019s mRESVIA for at-risk adults between the ages of 18 and 59\u2014broadening its eligible population beyond older adults.<\/p>\n
RSV is a widespread seasonal virus that often causes cold-like symptoms but can result in severe illness such as pneumonia, particularly among infants and the elderly. Expanding access to effective vaccines is seen as critical in mitigating the virus\u2019s health burden across different age groups.<\/p>\n
Currently, Arexvy is approved in the European Union for adults aged 60 and above. It also holds authorisation for use in high-risk adults between 50 and 59. If granted, the new label expansion would significantly widen its reach and potential impact across the adult population.<\/p>\n
The regulatory decision comes at a time when GSK is aiming to revitalise its vaccine sales. Arexvy generated \u00a30.1 billion ($135.4 million) in revenue in the first quarter of 2025\u2014a 57% year-on-year decline\u2014falling short of expectations. The company had originally projected peak annual sales for the vaccine to reach \u00a33 billion, but performance has lagged in recent quarters.<\/p>\n
GSK stated that a final decision from the EMA on the expanded indication is expected in the first half of 2026.<\/p>\n","protected":false},"excerpt":{"rendered":"
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