GSK announces that the European Medicines Agency (EMA) has agreed to consider its regulatory application to extend the use of Arexvy, its recombinant respiratory syncytial virus (RSV) vaccine, to adults aged 50-59 at increased risk of RSV disease.

If accepted, GSK's RSV vaccine would be the first available vaccine to help protect this population.

Arexvy is currently approved in Europe in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

This regulatory submission is based on a Phase III trial evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59.

A European regulatory decision is expected in the second half of 2024.

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