GSK’s older adult vaccine candidate for the treatment of respiratory syncytial virus (RSV) has been accepted for a Biologics License Application (BLA) and granted Priority Review by the US Food and Drug Administration (FDA), the company announced.
Priority Reviews are granted by the FDA in response to applications for vaccines that, if approved, have the potential to offer significant improvements in the safety or effectiveness of the treatment or prevention of critical conditions when compared to standard applications. The FDA’s action date for its regulatory decision is scheduled for 3 May 2023.
With the FDA’s approval, GSK’s RSV older adult vaccine candidate could have the potential to be a first-of-its-kind vaccine available for the protection of adults aged 60 years and older from lower respiratory tract disease (LRTD) as a result of RSV.
The older adult vaccine candidate uses a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. RSV is a common contagious virus affecting the lungs and airways, and is one of the major remaining infectious diseases which currently has no vaccine or specific treatment approved for adults anywhere worldwide.
Older adults are placed at a higher risk for severe disease as a result of age-related decline in immunity and underlying conditions. The virus can exacerbate such conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. It can also lead to pneumonia, hospitalisation and death.
Every year, RSV causes over 420,000 hospitalisations and 29,000 deaths in adults aged 60 years and older in industrialised countries.
The BLA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial, in which high overall vaccine efficacy against RSV LRTD in adults aged 60 years and older was demonstrated.
In addition, the trial showed that the vaccine was well tolerated with a favourable safety profile, while the most frequently observed adverse events were injection site pain, fatigue, myalgia and headache.
Moreover, the trial demonstrated consistently high vaccine efficacy against LRTD in severe disease, in adults aged from 70 to 79 years old, in adults with underlying comorbidities and efficacy spanning RSV A and B strains.
To date, the FDA’s acceptance for a Priority Review is the third key regulatory milestone for GSK’s RSV older adult vaccine candidate, as it follows regulatory submission acceptances by the European Medicines Agency and Japan’s Ministry of Health, Labour and Welfare.