The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above.
The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.
In May 2023, Arexvy received approval from the US Food and Drug Administration (FDA) for the same indication.
Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant.
The EC approval follows a positive opinion from the European Medicines Agency’s committee on medicinal products for human use (CHMP) in April 2023.
GSK chief scientific officer Tony Wood stated: “Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year.
“This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation.
“Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”
The marketing authorisation from the EC was supported by data obtained from a pivotal Phase III AReSVi-006 (adult respiratory syncytial virus) trial.
Arexvy demonstrated a statistically significant and clinically meaningful 82.6% overall efficacy against RSV-LRTD in adult patients.
Its efficacy in older adults with one or more underlying medical conditions such as certain cardiorespiratory and endocrine-metabolic disorders was 94.6%.
The vaccine will be available before the 2023/2024 RSV season, which usually begins in autumn.
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