Drugs

FDA OKs Meitheal’s Antibiotic for Urinary Tract Infections

FDA has approved a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible Escherichia coli and Klebsiella pneumoniae.

Fosfomycin is described by the company as a novel epoxide antibacterial and the only intravenous antibiotic of its kind approved in the U.S. It acts at an early stage of bacterial cell wall synthesis — earlier than β-lactam antibiotics — blocking the first committed step and effectively killing the bacteria, it says. The drug has no known cross-resistance with other antibiotic classes, according to Meitheal.

Approval was based on data from the Phase 2/3 ZEUS (ZTI-01) trial, which compared intravenous fosfomycin with piperacillin/tazobactam in hospitalized patients with cUTI. The company says the study showed noninferiority for Contepo on the primary endpoint of overall success — defined as clinical cure and microbiologic eradication — achieved by 63.5% of patients treated with fosfomycin versus 55.6% with piperacillin/tazobactam.

The treatment was generally well tolerated, it says, with the most common side effects including elevated liver enzymes, low potassium, neutropenia, nausea, and diarrhea.

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