Drugs

GSK Plans NDA for Antibiotic Gepotidacin

GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The submission will be based on “positive results” from the pivotal EAGLE-2 and EAGLE-3 Phase 3 trials that were stopped early for efficacy late last year based on a recommendation from an independent data monitoring committee, the company says.

In the studies, “gepotidacin demonstrated non-inferiority to nitrofurantoin, an existing first-line treatment for uUTI, in patients with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin,” GSK says. “Additionally, in the EAGLE-3 phase 3 trial, gepotidacin demonstrated statistically significant superiority versus nitrofurantoin.” The most common reported adverse events in patients taking gepotidacin were gastrointestinal-related.

GSK describes gepotidacin as a first-in-class triazaacenaphthylene antibiotic that “inhibits bacterial DNA replication by a novel mechanism of action and binding site and provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most strains of target uropathogens, such as E. coli and Staphylococcus saprophyticus, including isolates resistant to current antibiotics.”

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