British drugmaker GSK said today that the US Food and Drug Administration (FDA) has expanded the approved use of its respiratory syncytial virus (RSV) vaccine for younger adults at risk of complications from the virus.
In a news release, the company said the FDA approved Arexvy for use in adults aged 18 to 49 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV. The vaccine was previously approved for all adults aged 60 and over and those aged 50 to 59 at increased risk of LRTD caused by RSV.
2 million clinic visits a year
RSV is associated with an estimated 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits annually in adults aged 18 to 49, according to a study cited in the release. Hospitalizations are more likely to occur in younger adults with chronic medical conditions that can be exacerbated by RSV, such as cardiopulmonary or kidney disease, obesity, and diabetes.
GSK said the expanded approval is based on data from a phase 3b trial that showed a non-inferior immune response to the vaccine in younger adults compared with those 60 and older.
“This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system,” said Sanjay Gurunathan, MD, GSK’s head of vaccines and infectious diseases research and development.