Drugs

GSK and Spero’s Antibiotic Positive Phase 3 Results

GSK and Spero Therapeutics are announcing positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infections (cUTIs), including pyelonephritis. The findings are from the pivotal PIVOT-PO trial, which was stopped early for efficacy following a recommendation from an independent data monitoring committee. The companies said they plan to submit the data to FDA in the fourth quarter.

The late-stage PIVOT-PO trial compared oral tebipenem HBr (600 mg) with intravenous imipenem-cilastatin (500 mg) in 1,690 hospitalized adults with cUTI or pyelonephritis. Tebipenem HBr achieved a 58.5% overall success rate — defined as a composite of clinical cure and bacterial eradication — compared to 60.2% for imipenem-cilastatin, meeting the prespecified non-inferiority margin, according to the companies. Secondary endpoints also showed comparable performance — clinical cure: 93.5% (tebipenem) vs. 95.2% (IV imipenem), and microbiological response: 60.3% vs. 61.3%, respectively.

The oral drug’s safety profile was similar to that of IV carbapenem-class antibiotics, the companies say, adding that the most common adverse events were mild or moderate diarrhea and headache.

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