GSK’s Arexvy becomes first U.S.-cleared shot for respiratory syncytial virus
Sarah Silbiger
The Food and Drug Administration (FDA) on Wednesday approved Arexvy from GSK (NYSE:GSK), making the British pharma giant’s product the first U.S.-cleared shot for respiratory syncytial virus (RSV).
Arexvy is indicated for those aged 60 years and older to prevent lower respiratory tract disease caused by RSV. The approval comes after the agency accepted GSK’s biologics license application (BLA) for Arexvy under priority review last year with a regulatory action date of May 03, 2023.
GSK’s RSV older adult vaccine contains an adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (AGEN).
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” FDA’s vaccine chief Dr. Peter Marks remarked.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”
Meanwhile, Pfizer’s (PFE) rival RSV vaccine candidate is under the FDA review for disease prevention in older adults and infants, with decisions expected by May and August 2023, respectively.