EMA to review GSK’s Arexvy for RSV prevention in adults aged 50-59
Betsy Goodfellow | January 29, 2024 | News story | Medical Communications | Arexvy, EMA, Infections and infestations, RSV
GSK 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 protect adults aged 50-59 who are at an increased risk of RSV disease.
If this is accepted, GSK’s vaccine, Arexvy, would be the first vaccine approved for this patient population. The vaccine is already approved in Europe for the protection of adults aged 60 and over against lower respiratory tract disease (LRTD) caused by RSV.
This submission follows positive results from a phase 3 trial which assessed the immune response from the vaccine in adults aged 50-59 including those with an underlying medical condition which could make them more vulnerable to RSV-LRTD.
According to the company’s press release: “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 to extend the approval to this patient population, and an EMA decision is expected in the second half of 2024.
Betsy Goodfellow
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