GSK hails success in US RSV vaccine trial
Pharma giant GSK has announced positive preliminary results from a trial of its Arexvy vaccine to treatment respiratory syncytial virus (RSV) disease for a younger patient population in the US.
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The vaccine, which is currently approved in the States for the prevention of RSV-lower respiratory tract disease (LRTD) in adults aged 60 and above, was trialled on adults aged 50 to 59.
Arexvy, which has already been approved in Europe, Japan and several other countries, "elicited an immune response [...] that was non-inferior to that observed in adults aged 60 and above, meeting the trial's primary co-endpoint", GSK said in a statement on Wednesday.
RSV is a common, contagious virus that can cause severe respiratory illness, especially for older populations who may be immunocompromised or have underlying medical conditions.
These results will be presented at the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting later today, and submitted to the Food and Drug Administration and other regulatrs to support potential label expansions.
Tony Wood, GSK's chief scientific officer, said: "This trial reinforces our confidence in our RSV vaccine's ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD. We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time."