Drugs

GSK sNDA for Oral Gonorrhoea Treatmemt

FDA has accepted for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 and older. The agency has set a user fee review action target date of 12/11.

If approved, gepotidacin would become the first oral option for gonorrhoea treatment in the U.S., where current standard therapy relies on injectable antibiotics that may not be suitable or accessible for all patients, the company says. Gonorrhoea, caused by Neisseria gonorrhoeae, is the second most commonly reported sexually transmitted infection in the country, with over 600,000 cases reported in 2023, according to the U.S. Centers for Disease Control and Prevention.

GSK says the submission is backed by positive Phase 3 data from the EAGLE-1 trial that compared gepotidacin (two 3,000 mg oral doses) with the leading combination therapy of intramuscular ceftriaxone plus oral azithromycin. Gepotidacin achieved a 92.6% success rate at the urogenital site, comparable to 91.2% for the standard regimen, with no treatment failures from bacterial persistence in either group. Safety findings were consistent with prior studies, with no serious drug-related adverse events reported and mild-to-moderate gastrointestinal issues as the most common side effects, it says.

Gepotidacin is currently approved for uncomplicated urinary tract infections. It is said to work by targeting bacterial DNA replication through a novel binding site, offering potential activity against drug-resistant strains.

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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