GlaxoSmithKline's (NYSE:GSK) respiratory syncytial virus (RSV) vaccine, Arexvy, has shown positive preliminary results in a phase III trial involving adults aged 50-59 at increased risk of RSV lower respiratory tract disease (LRTD). The findings revealed that the vaccine elicited an immune response non-inferior to that in older adults, meeting its primary co-endpoints.
The phase III trial was a placebo-controlled, randomized study conducted across eight countries with approximately 1,520 participants. It assessed the immune response and safety in participants aged 50-59 with chronic diseases leading to an increased risk of RSV disease after a single dose of Arexvy. Common adverse events included pain, fatigue and headache.
RSV is a common virus that can cause severe respiratory illness and exacerbate conditions like chronic obstructive pulmonary disease (COPD), asthma, and heart failure. Infection and hospitalization rates may be higher than reported in many high-income countries.
Arexvy, which contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant system containing QS-21 STIMULON adjuvant, is already approved for active immunisation against RSV-LRTD in adults aged 60 and older in the US, Europe, Japan, and other countries. The vaccine received US FDA approval on May 3, 2023, European Commission authorization in June 2023, and approval from Japan’s Ministry of Health in September 2023.
Tony Wood, Chief Scientific Officer at GSK, expressed confidence in Arexvy's ability to protect adults aged 50 to 59 at increased risk for RSV-LRTD. He announced plans to submit these data for regulatory review as quickly as possible. GSK is set to be the first company to submit data for this population to regulators, with decisions on potential label expansion expected in 2024.
The final results from the trial will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The data will also be submitted to the US FDA and other regulators to support potential label expansions.
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