Drugs

GSK NDA Accepted for New Antibiotic

FDA has accepted for priority review a GSK NDA for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for treating female adults and adolescents with uncomplicated urinary tract infections (uUTIs). The company says new treatments are needed as uUTIs caused by drug-resistant bacteria are increasing, which can lead to higher treatment failure rates. The agency has set a user fee review action target date of 3/26/2025.

GSK says gepotidacin works by inhibiting bacterial DNA replication by a distinct binding site that “provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics.”

The submission is based on data from the pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. In the studies, GSK says gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin — 58.5% of participants treated with gepotidacin had therapeutic success compared to 43.6% for those treated with nitrofurantoin. In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% of participants compared to 47.0% for those taking nitrofurantoin.

GSK says gepotidacin’s safety and tolerability profile was consistent with previous trials of the antibiotic. The most common reported adverse events were diarrhea (16% of participants) and nausea (9%).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome