GSK said Arexvy, its vaccine for respiratory syncytial virus (RSV) showed positive preliminary results in a late-stage trial to protect adults aged 50 to 59 from the disease that causes thousands of hospitalisations and deaths annually.
The British drugmaker’s shot, called Arexvy, met the primary goal in the Phase-III trial of eliciting an immune response in adults of the reported age group who are at an increased risk of catching the virus due to certain underlying medical conditions, the company said on Wednesday.
RSV typically causes cold-like symptoms, but is a leading cause of pneumonia in toddlers and the elderly.
The shot has already been approved in the United States, Europe, Japan and other countries to protect adults aged 60 years and older.
About Arexvy (respiratory syncytial virus vaccine, adjuvanted)
Respiratory syncytial virus vaccine, adjuvanted, contains recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.
The vaccine was approved by the US FDA on 3 May 2023 for the prevention of LRTD caused by RSV in individuals 60 years of age and older.
In June 2023, the European Commission authorised the vaccine for active immunisation for the prevention of LRTD caused by RSV in adults aged 60 years and older.
In September 2023, Japan’s Ministry of Health, Labour and Welfare approved the vaccine for the prevention of RSV disease for adults aged 60 years and above.
The vaccine has also been approved in the UK and Canada. Regulatory reviews in other countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
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