GSK will begin to offer Arexvy before the onset of the 2023/2024 RSV season. Credit: GSK plc.

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.

Related Company Profiles

View all

Last month, 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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 begins later this year.