Drug Approval | May 12, 2023
USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
RSV is the most common viral cause of respiratory tract infections in newborns, young children, older adults, or the immunocompromised
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available
ENFLONSIA is a long-acting monoclonal antibody designed to shield infants through a typical five-month RSV season with a single, fixed dose
The data will be presented at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Munich, April 17-21
RSM01, a preventive treatment targeting respiratory syncytial virus (RSV), was licensed earlier this month from the Gates Medical Research Institute
Previously, Arexvy was authorized for adults 60 and older, and for those 50–59 with heightened risk
The data highlights its RSV vaccine cuts hospitalizations in older adults
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