GSK's RSV Vaccine Approved for Older Adults by FDA
May 03 2023 - 01:43PM
Dow Jones News
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.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
May 03, 2023 13:28 ET (17:28 GMT)
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