GlaxoSmithKline (GSK) has received the US Food and Drug Administration (FDA) expanded approval for its adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy.
Arexvy was previously approved in the US, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and above.
The current FDA approval expands its indication to include adults aged 50 through 59 years, who are at elevated risk of LRTD.
Arexvy contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3), combined with GSK’s unique AS01E adjuvant.
The AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics, a wholly owned subsidiary of Agenus.
British drugmaker
GSK chief scientific officer Tony Wood 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.”
The expanded FDA approval is supported by positive results from a Phase 3 placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial of Arexvy.
The study evaluated the immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk for RSV-LRTD.
In the study, the vaccine met the primary endpoints of the Phase 3 study, including RSV-A and RSV-B neutralisation titres of both groups, compared to adults aged 60 and above.
It also met the safety and immunogenicity secondary and tertiary endpoints and showed safety and reactogenicity data that were consistent with results from the initial data read-out.
The most common adverse events include pain, myalgia, fatigue, and headache.
GSK has also filed regulatory submissions to expand the indication of its RSV vaccine to include adults aged 50-59 at increased risk, in Europe, Japan and other geographies.
University of Rochester School of Medicine professor Ann Falsey said: “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD.
“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider.
“Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions.”
