GSK’s RSV Vaccine Approved By FDA For High-Risk Adults in Expanded Age Range

GSK's (LON: GSK) RSV vaccine, Arexvy, has been approved by the FDA for use in adults aged 50-59 who are at increased risk of severe RSV outcomes, the company said late Friday.

This expands the age range for the vaccine, which was previously only approved for adults 60 and older.

This age group includes over 13 million adults in the US with underlying medical conditions like COPD, asthma, heart failure, and diabetes. These conditions can increase the risk of serious complications from RSV infection.

GSK's approval for the expanded age range was supported by a Phase 3 trial showing the vaccine's safety and effectiveness in adults aged 50-59, including those with high-risk conditions.

GSK is also seeking approval for this age group in Europe, Japan, and other countries. The company adds that trials to evaluate the vaccine in younger adults (18-49) and immunocompromised adults are ongoing, with results expected later in 2024.

Tony Wood, Chief Scientific Officer at GSK, said: “Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk.

“For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”

Last week, GSK shares plunged more than 9% after a Delaware judge ruled on May 31 that over 72,000 lawsuits regarding discontinued heartburn drug Zantac could go ahead.

Despite the decline, the stock is still up more than 11% this year, trading around the 1,629p mark.