LONDON (dpa-AFX) - GSK plc (GSK.L) Thursday said the European Commission has approved its respiratory syncytial virus (RSV) vaccine Arexvy for adults aged 50-59 who are at increased risk.
The approval was supported by positive results from a phase 3 study of Arexvy in adults aged 50-59, including those at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus due to certain underlying medical conditions.
Arexvy is already approved in the U.S. and Europe for adults aged 60 and over. It is also approved in the U.S for adults aged 50-59 who are at increased risk.
It is estimated that there are about 65 million adults aged between 50 and 59 in the European Union/European Economic Area, with about 20 million of these people having at least one underlying medical condition that puts them at increased risk for RSV disease, GSK said.
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