FDA extends approval for GSK’s RSV vaccine, AREXVY, to adults aged 50-59 at increased risk

The U.S. Food and Drug Administration (FDA) has officially broadened the age indication for GSK plc’s (LSE/NYSE: GSK) AREXVY, marking it as the first adjuvanted Respiratory Syncytial Virus (RSV) vaccine authorized for adults aged 50-59 who are at heightened risk of severe outcomes from the virus. This extension builds on the existing approval for individuals aged 60 and older.

Approval for Expanded Demographic:

In a significant development for public health, GSK’s AREXVY now offers protection against lower respiratory tract disease (LRTD) caused by RSV for a wider age group. This comes as a response to data indicating over 13 million U.S. adults in this age bracket have underlying conditions making them more susceptible to serious RSV complications.

The FDA has expanded approval for GSK’s AREXVY RSV vaccine to include adults aged 50-59 at increased risk. Photo courtesy of Business Wire.

Clinical and Regulatory Advancements

Supporting Data and Continued Trials: The FDA’s decision was propelled by positive outcomes from a Phase III trial, assessing the immune response and safety of the vaccine in the newly included age group. With RSV responsible for approximately 42,000 hospitalizations annually among adults aged 50-64, the expanded approval could significantly reduce hospital visits and severe health episodes among at-risk populations.

The ongoing clinical development program is set to further explore the vaccine’s efficacy in adults over 18, with anticipated data readouts in the second half of 2024. GSK has also initiated regulatory filings to extend the vaccine’s use in Europe, Japan, and other regions, with decisions pending.

Expert Opinions and Future Outlook

Professor Ann R. Falsey of the University of Rochester School of Medicine welcomed the approval, emphasizing the importance of addressing RSV risks in adults with pre-existing health issues. GSK’s Chief Scientific Officer, Tony Wood, highlighted the strategic importance of widening the vaccine’s reach to better protect vulnerable populations.

AREXVY’s active ingredient, the RSVPreF3 antigen, is enhanced with GSK’s proprietary AS01E adjuvant for improved immune response. This formulation aims to provide robust protection against RSV-induced LRTD, supporting its use as per official recommendations.

Continued Global Approvals and Proprietary Technology

The vaccine is already sanctioned in over 40 countries for individuals 60 years and older. Its broader approval could redefine preventive health strategies globally, especially among adults at increased risk due to underlying conditions such as COPD, asthma, heart failure, and diabetes.

The expanded FDA approval of AREXVY represents a pivotal advancement in the fight against RSV, potentially setting a new standard in vaccine preventative care for at-risk adult populations worldwide. As GSK continues to pursue approvals in other regions, the global health community watches closely, anticipating the wider implications of this breakthrough.