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GSK PLC on Monday announced that the US Food & Drug Administration has approved an expanded age indication for its respiratory syncytial virus vaccine. The London-based pharmaceutical manufacturer said the FDA has approved Arexvy for the prevention of RSV lower respiratory tract disease, in adults aged 50 to 59 years who are at increased risk. Arexvy was already approved for use in adults aged 60 and older. RSV is a common and contagious respiratory virus which causes cold-like symptoms. Most people experience mild illness, but infants and older adults are both more likely to develop severe symptoms which require hospitalisation. GSK said that according to a systematic review of US studies, RSV causes an estimated 42,000 hospitalisations per year in adults aged 50 to 64 years old. ‘Adults 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 conditions,’ GSK added. ‘RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.’ GSK said the FDA application was supported by positive results from a phase 3 trial evaluating the vaccine’s immune response and safety in adults aged 50 to 59, including people at increased risk for RSV-LRTD due to underlying conditions. GSK said it also has filed regulatory submissions to extend the vaccine’s use to adults aged 50 to 59 at higher risk in Europe, Japan and other geographies. Furthermore, it expects to announce results for trials in adults aged 18 to 49 at higher risk, and immunocompromised adults aged 18 and over, in the second half of this year. ‘Today’s approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50 to 59 who are at increased risk,’ Chief Scientific Officer Tony Wood commented. ‘For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.’ Shares in GSK were down 1.0% at 1,612.00 pence in London on Monday morning. Copyright 2024 Alliance News Ltd. All Rights Reserved.
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