By Fineline Cube 
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that the European Medicines Agency (EMA) has accepted its regulatory submission to expand the indication of its adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18 years and older.A regulatory decision is anticipated in the first half of 2026.
Current Approval Status
Arexvy is already approved in over 60 countries for the prevention of RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 years and older. Additionally, it is authorized in more than 50 markets including the U.S., Japan, and Europe for high-risk adults aged 50 – 59 with underlying conditions that increase their risk of RSV.The company is also pursuing similar label expansions in other key markets such as the U.S. and Japan.
Regulatory Expansion Strategy
GSK’s move to expand the indication of Arexvy highlights the company’s commitment to addressing the burden of RSV across a broader adult population. The acceptance of the regulatory submission by the EMA is a significant step forward in potentially offering protection to younger adults who may also be at risk of RSV-related complications.
Market Impact and Public Health Significance
If approved, the expanded indication could have a substantial impact on public health by reducing the incidence of severe RSV infections in a wider adult population. It may also influence vaccination strategies and guidelines across various regions, further solidifying GSK’s position in the RSV vaccine market.-Fineline Info & Tech