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GSK’s RSV drug Arexvy accepted for regulatory review in Europe

ALN

GSK PLC on Friday said its respiratory syncytial virus vaccine, Arexvy, has been accepted for regulatory review by the European Medicines Agency to expand its use in adults 18 years and older.

The London-based pharmaceuticals company said a European regulatory decision on this submission is anticipated in the first half of 2026.

Arexvy was the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older, and for those aged 50 to 59 years who are at increased risk for RSV disease, GSK noted.

RSV is a common contagious virus affecting the lungs and breathing passages and is suffered by an estimated 64 million people of all ages globally every year.

GSK said it is continuing to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.

Shares in GSK were 0.3% lower at 1,544.50 pence each in London on Friday morning. The wider FTSE 100 was down 0.6% in early trade.

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