Ildar Imashev
GlaxoSmithKline (NYSE:GSK) announced late Friday that the U.S. Food and Drug Administration approved Arexvy, a respiratory syncytial virus (RSV) vaccine for adults ages 50-59 who are at higher risk for infection, expanding its current label for older adults.
With this decision, the UK Drugmaker surpasses Pfizer (PTFE) and modern (Messenger RNA), its rival in the RSV vaccine space, expanded use of Arexvy, which contains an Agenus-licensed adjuvant (NASDAQ:Agen).
Last year, GSK (GSK), as well as Pfizer (PFE), received FDA approval to market their RSV vaccines, Arexvy and Abrysvo, for people 60 years of age and older to prevent the lower respiratory tract disease (LRD) caused by the Virus.
Just last week, Moderna (MRNA) announced that the agency approved its messenger RNA-based vaccine, mRESVIA, to prevent RSV-related LRD in the same age group.
GlaxoSmithKline (GSK) said European, Japanese and other regulators are also conducting reviews to expand the use of its RSV vaccine in high-risk adults aged 50-59.
The company expects to test Arexvy in the second half of 2024 in high-risk adults 18-49 years of age and immunocompromised adults 18 years and older.
