GSK Reports Positive Phase 3 Data for UTI Oral Antibiotic
April 17 2023 - 1:51AM
Dow Jones News
By Elena Vardon
GSK PLC on Monday reported positive data from its phase 3
studies for gepotidacin, its late-stage oral antibiotic for
uncomplicated urinary-tract infections in female adults and
teenagers.
The pharmaceutical giant said the EAGLE-2 and EAGLE-3 phase 3
trials met the primary endpoint of non-inferiority to
nitrofurantoin, an existing treatment, demonstrating therapeutic
success in 50.6% of patients against 47%. EAGLE-3 showed
statistical superiority to nitrofurantoin with 58.5% success
compared with 43.6%, it added.
It said it plans to submit it to the U.S. Food and Drug
Administration in the second quarter of 2023.
GSK added the data shows potential for what could be the first
new oral antibiotic for the common ailment in more than two
decades.
Write to Elena Vardon at elena.vardon@wsj.com
(END) Dow Jones Newswires
April 17, 2023 02:36 ET (06:36 GMT)
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