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GSK’s Arexvy on track for wider age range approval in Europe

ALN

GSK PLC on Friday said European regulators have recommended broadening the indication for its Arexvy vaccine to all adults aged 18 and older.

The London-based pharmaceutical firm expects marketing authorisation in February, when the European Medicines Agency is due to follow up its positive opinion with a final decision.

Arexvy targets recombinant respiratory syncytial virus, a contagious disease which affects the lungs, and is diagnosed in roughly 64 million people annually, according to research cited by GSK. The vaccine combines an antigen with the drug company’s proprietary AS01E adjuvant.

It is currently approved in Europe to prevent RSV-caused lower respiratory tract disease in those aged 60 or older, and in 50- to 59-year-olds who are more likely to develop RSV.

GSK also aims to expand the indication in the US and Japan.

‘Today’s positive CHMP opinion is an important step towards bringing more options to prevent severe RSV disease for adults in Europe,’ commented Sanjay Gurunathan, GSK’s head of vaccines and infectious diseases research & development.

‘GSK is dedicated to increasing access to our vaccines in broader adult populations and we continue to drive innovation to help make it easier for healthcare professionals to offer protection against severe RSV disease.’

The company’s shares were up 0.5% to 1,830.00 pence on Friday morning in London.

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