GSK has announced that its respiratory syncytial virus (RSV) vaccine has been accepted for priority review by the US Food and Drug Administration (FDA) for use in adults aged 50 to 59 years who are at an increased risk for RSV disease.
If approved, Arexvy would be the first vaccine available to help protect this patient population.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, certain populations are at a higher risk for severe disease, such as older adults, the immunocompromised and those with underlying medical conditions.
Arexvy has already been approved in the US, Europe and several other countries to protect adults aged 60 years and older against RSV-caused lower respiratory tract disease (LRTD).
GSK’s application to extend the indication is supported by results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at increased risk for RSV-LRTD due to underlying medical conditions.
The company recently shared positive results from the trial, which showed that Arexvy elicited an immune response in this population, including those with chronic pulmonary disease, cardiovascular disease, kidney disease, liver disease or diabetes, that was non-inferior to that observed in adults aged 60 and above.
The co-primary endpoint was also met for the broader group of adults in this age group, GSK said in the October readout, adding that safety and reactogenicity data was consistent with results from the initial phase 3 programme of Arexvy.
Final results from the trial will be presented at an upcoming medical conference and the company has outlined that the data will be submitted to other regulators to support potential label expansions.
GSK used a priority review voucher to reduce the FDA’s review period for the expanded use of Arexvy by four months, with the regulator set to make a final decision in June this year.
GSK’s original application for the use of Arexvy in adults aged 60 years and older 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 this age group.