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GSK PLC on Friday said that a new drug application for its respiratory syncytial virus vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour & Welfare.
GSK is a Brentford, London-based biopharmaceutical firm, which amongst other projects is working on vaccine therapies to treat RSV, a common contagious virus affecting the lungs and breathing passages.
RSV is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment available for adults. Older adults are particularly at risk, as RSV can exacerbate conditions such as chronic obstructive pulmonary disease, asthma and chronic heart failure.
GSK's proposed indication is for adults aged 60 years and above to prevent lower respiratory tract diseases caused by RSV.
It said the filing was based on positive data from a prespecified interim analysis of the AReSVi-006, or adult respiratory syncytial virus, phase three trial.
Results from the trial showed high overall vaccine efficacy against lower respiratory tract diseases caused by RSV in adults over 60, with a favourable safety profile.
Consistent high vaccine efficacy was observed against lower respiratory tract diseases in severe disease, adults aged 70 to 79 years, adults with underlying co-morbidities, and across RSV A and B strains.
GSK said it expects further announcements on regulatory progress in the US and Europe before the end of 2022. There are currently no RSV vaccines for adults approved anywhere in the world.
GSK shares were trading 0.6% higher at 1,372.80 pence each in London on Friday morning.
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