GSK Stops Patient Enrolment for Gepotidacin Early Following IDMC Review
November 03 2022 - 3:55AM
Dow Jones News
By Ian Walker
GSK PLC said Thursday that it will stop patient recruitment
early for two trials of gepotidacin, a treatment for urinary tract
infections, following a recommendation by the Independent Data
Monitoring Committee.
The pharmaceutical giant said that the decision was based on a
pre-specified interim analysis of efficacy and safety data in more
than 3,000 patients across the trials. However, it added that the
IDMC review didn't identify any safety concerns.
The EAGLE-2 and EAGLE-3 trials met the primary efficacy
endpoint, GSK said. The company also said that it plans to submit a
new drug application for gepotidacin with the U.S. Food and Drug
Administration in the first half of next year.
"The IDMC's recommendation to stop the EAGLE-2 and 3 trials
early for efficacy provides GSK with the opportunity to engage
regulatory authorities as we work together to bring a new class of
antibiotics to patients with uUTIs [Uncomplicated urinary tract
infections]," GSK's senior vice president for development Chris
Corsico said.
Write to Ian Walker at ian.walker@wsj.com
(END) Dow Jones Newswires
November 03, 2022 03:40 ET (07:40 GMT)
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