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FDA approves Arexvy for patients 50–59

On June 7, the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GSK’s Arexvy, making it the first respiratory syncytial virus (RSV) vaccine for adults aged 50–59 at increased risk. With this approval, patients between the ages of 50 and 59 with certain underlying conditions (like chronic obstructive pulmonary disease, asthma, heart failure, and diabetes) have access to the vaccine as part of the annual vaccine schedule.

“Today’s approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50–59 who are at increased risk,” said Tony Wood, Chief Scientific Officer at GSK. “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.”

GSK is a member of the Biotechnology Innovation Organization (BIO).

What is Arexvy?

Arexvy was approved by the FDA in May 2023, making it the second RSV vaccine approved that year. Arexvy was added to the recommended list of annual vaccines by the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention (CDC/ACIP).

Prior to Friday’s decision, RSV immunization was only available for older adults (with GSK’s Arexvy and Pfizer’s Abrysvo) and pediatric space (with the monoclonal antibody Beyfortus developed by AstraZeneca and Sanofi, and Sobi’s Synagis). And before 2023, there were no RSV vaccines or immunizations at all.

“A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old,” says GSK’s press release. “Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.”

“I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50–59 at increased risk of RSV-LRTD,” said Professor Ann R. Falsey, University of Rochester School of Medicine. “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. Now there is a vaccine approved that can help protect them.”

What’s next for Arexvy?

While Arexvy has gotten the green light stateside, GSK is working to file regulatory submissions in Europe, Japan, and other geographies for its use in adults aged 50–59 at increased risk. The regulatory decisions are currently undergoing review.

Later this year, GSK expects results from trials evaluating the immunogenicity and safety of the vaccine in adults aged 18–49 at increased risk, and immunocompromised adults aged 18+.