GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older.
The decision makes Arexvy the first RSV vaccine for older adults to be authorised for use in Great Britain by the MHRA, the drugmaker said.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease.
This is partly due to an age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma, and chronic heart failure.
Overall, RSV infections in older adults account for an estimated 14,000 hospitalisations and 8,000 deaths each year in the UK.
GSK’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older – the trial’s primary endpoint.
Positive vaccine efficacy was also observed in those with comorbidities of interest, such as certain cardiorespiratory and endocrino-metabolic conditions, which the company says reinforces the impact the vaccine could have on those most at risk of severe RSV outcomes.
Neale Belson, senior vice president and general manager UK at GSK, said: “We are very excited by [the] 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.
“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 comes just over a month after Arexvy was approved by the European Commission for the same patient population, making it the first RSV vaccine for older adults to be granted European Marketing Authorisation.
The vaccine was also approved in the US the month prior for the same patient population, and regulatory reviews in Japan and several other countries are ongoing.