British biopharma company GSK plc (GSK,GSK.L) announced Wednesday that the US Food and Drug Administration has accepted a Biologics License Application or BLA and granted Priority Review for its respiratory syncytial virus or RSV older adult vaccine candidate.
RSV is a common contagious virus affecting the lungs and breathing passages, for which there is currently no vaccine or specific treatment available for adults.
The FDA has set a Prescription Drug User Fee Act action date for their regulatory decision of May 3, 2023.
If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
GSK noted that the BLA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial. The data showed high overall vaccine efficacy against RSV lower respiratory tract disease or LRTD in adults aged 60 years and older. The vaccine was well tolerated with a favourable safety profile.
Further, consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities and across RSV A and B strains.
A Priority Review designation means the US FDA’s goal is to expedite review of a BLA, reducing the review period by four months.
The company noted that this is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan.
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