Grandbrothers
GSK (NYSE:GSK) announced Tuesday that the U.S. FDA accepted its marketing application to evaluate a label expansion for its respiratory syncytial virus (RSV) vaccine, Arexvy, for those aged 50–59 years under priority review.
The regulator has issued June 7, 2024, as the target action date for its decision after the company used a priority review voucher to cut the review period.
Arexvy is developed using an adjuvant licensed from Antigenics Inc., a wholly-owned subsidiary of Agenus Inc. (AGEN).
In May 2023, GSK (GSK) won FDA approval for Arexvy for those aged 60 and older, making the product the first U.S.-cleared shot against RSV.
A few weeks later, Pfizer (PFE) won FDA approval for its rival shot, Abrysvo, sparking a battle between the two pharma giants in a market where roughly 177K older adults are hospitalized each year due to RSV.