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GSK’s Arexvy authorised by MHRA

Therapy is the first respiratory syncytial virus vaccine specifically developed for older adults.

GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy. The therapy is for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) among adults of 60 years and above.

It is the first time an RSV vaccine, specifically for older adults, has been authorised for use across Great Britain by the MHRA.

The authorisation follows data from the critical AReSVi-006 phase 3 vaccine efficacy study, published in the New England Journal of Medicine. During the trial, there was high overall vaccine efficacy against RSV-LRTD, including in participants with a variety of underlying medical conditions.

Furthermore, the vaccine was generally well tolerated, while the most prevalent adverse events were injection site pain, myalgia, fatigue, arthralgia and headaches. The events were generally mild-to-moderate.

Neale Belson, senior vice president, and general manager UK at GSK, elaborated: “We are very excited by today’s announcement. Our ambition is to help protect adults 60 years of age and older in the UK who are at risk from RSV disease, including those with underlying medical conditions, who drive the majority of RSV hospitalisations.”

He added: “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.”

The MHRA’s decision arrives after the European Commission’s authorisation of Arexvy this year. GSK’s marketing authorisation application in the EU was reviewed under the ‘accelerated assessment mechanism’ because prevention of RSV illness in the older adult population is still considered a significant public health interest.

RSV remains a common and contagious respiratory virus that leads to an estimated 175,000 GP visits, 14,000 hospitalisations and 8,000 deaths each year in adults aged 60 years and over in the UK.

Arexvy was the world’s first RSV vaccine for older adults to be approved by the US Food and Drug Administration, while regulatory reviews are currently unfolding in Japan along with several other countries.