GSK PLC on Thursday said its respiratory syncytial virus vaccine candidate has gained positive opinion from the European Medicines Agency body.
The Brentford, London-based pharmaceutical firm said the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in adults.
RSV is a common contagious virus affecting the lungs and breathing passages.
GSK said the positive opinion was based on data from the AReSVi-006 phase III vaccine efficacy trial, where the vaccine candidate demonstrated 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older.
‘This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission,’ GSK said.
If approved, the firm said the candidate has the potential to be the first vaccine available to help protect older adults from RSV disease.
The final decision is expected by July this year.
Shares were up 1.9% at 1,469.00 pence each on Thursday morning in London.
Copyright 2023 Alliance News Ltd. All Rights Reserved.