GSK Seeks FDA Approval For Oral Antibiotic For Urinary Tract Infections, Probably First In New Class In Over 20 Years
Portfolio Pulse from Vandana Singh
GSK has submitted a marketing application to the FDA for gepotidacin, a new oral antibiotic for urinary tract infections, which could be the first in its class in over 20 years. The FDA has granted Priority Review with a decision expected by March 2025. Gepotidacin showed promising results in phase 3 trials, outperforming the current standard treatment, nitrofurantoin.
October 16, 2024 | 3:35 pm
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GSK's application for gepotidacin, a new oral antibiotic for UTIs, has been accepted by the FDA with Priority Review. This could be the first new class of oral antibiotics for UTIs in over 20 years, potentially boosting GSK's infectious disease portfolio.
The FDA's acceptance of GSK's application for gepotidacin with Priority Review indicates a potentially significant advancement in UTI treatment. The promising trial results and the potential to be the first new class of oral antibiotics in over 20 years could positively impact GSK's stock as it strengthens their infectious disease portfolio.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100