By Christian Moess Laursen
GSK said Wednesday that it has received authorization for its respiratory syncytial virus vaccine Arexvy from the European Commission, the executive body of the EU.
The London-listed pharmaceutical giant said the vaccine will help protect adults 60 years of age or older in 30 European countries from RSV disease for the first time. It is the first time an RSV vaccine for older adults have been granted European marketing authorization, it said.
The first launches are planned ahead of the 2023-24 RSV season which typically starts in the autumn, GSK said.
In Europe, RSV leads to over 270,000 hospitalizations and around 20,000 in-hospital deaths in adults aged 60 or older.
The authorisation is based on phase 3 efficacy data in older adults, GSK said.
Write to Christian Moess Laursen at christian.moess@wsj.com
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