GSK UTI treatment gets FDA priority review status
GSK
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GSK announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for gepotidacin, a first-in-class oral antibiotic, under priority review.
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The FTSE 100 pharmaceuticals giant said gepotidacin was being developed to treat uncomplicated urinary tract infections (uUTIs) in female adults and adolescents, potentially becoming the first new oral antibiotic class for the condition in over 20 years.
It said the FDA was expected to make its decision by 26 March next year.
The NDA submission was backed by positive results from the pivotal phase three EAGLE-2 and EAGLE-3 trials.
In both studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard treatment for uUTIs.
GSK said that in the EAGLE-3 trial, gepotidacin also showed statistically significant superiority over nitrofurantoin, achieving therapeutic success in 58.5% of participants, compared to 43.6% for nitrofurantoin.
Gepotidacin's safety profile was consistent with prior studies, with gastrointestinal issues, including diarrhoea and nausea, being the most common adverse events.
They were mostly mild to moderate in severity.
The antibiotic's development was being partially funded by the US Department of Health and Human Services and the Defense Threat Reduction Agency.
At 0822 BST, shares in GSK were up 0.4% at 1,500p.
Reporting by Josh White for Sharecast.com.