Drugs

Mortality Concerns Cloud Shionogi’s Cefiderocol: FDA

FDA drug reviewers appear to be focused on mortality concerns with a Shionogi NDA for cefiderocol injection that heads to an advisory committee vote 10/16 for its proposed indication to treat complicated urinary tract infections (cUTI). According to just-posted briefing materials, the agency aims to have a discussion on a “finding of increased mortality in the CREDIBLE-CR study in the overall risk benefit considerations for cefiderocol” and it seeks input on whether labeling will suffice to describe the risk or there is a need for additional studies. Cefiderocol is a siderophore cephalosporin with shown activity against several gram-negative bacteria.

The materials note that while the safety and efficacy of cefiderocol have been demonstrated for the treatment of cUTI, “higher mortality in cefiderocol-treated patients was observed in a trial in critically ill patients with a variety of infections due to carbapenem-resistant organisms... While no specific reason for the imbalance in mortality could be identified, it appears that some of the deaths were related to progression of infection/lack of clinical response and were more common in patients with infections due to organisms such as A. baumannii, S. maltophilia, and P. aeruginosa. Whether this difference in mortality is a chance finding or truly reflects a deficit in the activity of cefiderocol in critically ill patients is unclear.”

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