Drugs

Innoviva NDA for Gonorrhea Antibiotic Accepted by FDA

FDA has accepted for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinetrione oral antibiotic for treating uncomplicated gonorrhea in adults and pediatric patients 12 years and older. Innoviva says that if approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.

“The FDA’s acceptance of the zoliflodacin NDA is based on the totality of data collected from several clinical trials as part of an innovative public-private partnership with GARDP [Global Antibiotic Research & Development Partnership],” the company says. It includes data from a pivotal Phase 3 clinical trial, which demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin, Innoviva says. The study also showed that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial, it adds.

“Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction,” Innoviva says. “In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other 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