The FDA on Friday expanded GSK’s RSV vaccine to people ages 50 to 59 who are at an increased risk of the virus, marking another win for the blockbuster shot.
GSK’s Arexvy, which was first approved in May of last year for people who are 60 years old and older, raked in £1.2 billion ($1.5 billion) in sales in 2023, surpassing sales of Pfizer’s shot, which was approved in the same month. The company said that 8 million doses of Arexvy have been administered.
About 13 million adults over the age of 50 have a comorbidity like asthma or chronic obstructive pulmonary disease that puts them at high risk for severe RSV, according to Len Friedland, vice president and director of scientific affairs and public health at GSK. He told Endpoints News ahead of the approval that when these patients are hospitalized with RSV, they often remain in the hospital for multiple days, and some end up in the intensive care unit.
“It’s quite a large number of people,” Friedland said. “You may be 50 today, but when you’re 53, you may be diagnosed with congestive heart failure, etc.”
The approval is based on clinical trial results showing that the vaccine elicited an immune response that was non-inferior to that in the 60 and older age group. There were no new safety signals that arose in this population that weren’t already observed in the 60 and older group.
GSK is also evaluating Arexvy in people ages 18 and older who are immunocompromised or are at increased risk for RSV, and the company is planning to publish data for that group later this year. GSK is also evaluating co-administration of Arexvy with other vaccines, including flu, Covid-19 and shingles.
The RSV vaccine market is getting increasingly competitive. GSK predicts Arexvy will bring in $3 billion in sales at its peak. Pfizer is also looking to expand its RSV vaccine in adults ages 18 and older, and Moderna just scored a win from the FDA, winning approval last month for its vaccine, branded as mResvia, for adults ages 60 and over.
Next up, the CDC’s vaccine advisory committee is set to review the new indication later this month and make a recommendation on which populations should receive the vaccine.