By Joe Hoppe
GSK PLC said late Wednesday that its Arexvy respiratory syncytial virus vaccine for older adults has been approved by the U.S. Food and Drug Administration for the prevention of lower respiratory tract disease.
The pharmaceutical major said the approval–based upon positive Phase 3 trial data that showed exceptional efficacy in older adults–is the first in the world to be approved for individuals aged 60 years or older.
In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy, including among those with underlying medical conditions and those with severe RSV disease, and was well tolerated with an acceptable safety profile.
“Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries,” GSK Chief Scientific Officer Tony Wood said.
The drug is expected to be launched in the U.S. before the 2023-2024 RSV season.
RSV is a common, contagious virus that can lead to potentially serious respiratory illness, causing an estimated 14,000 deaths in the U.S. in adults aged 65 years and older each year.
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