Drugs

Partial Hold on Kezar’s Zetomipzomib Lifted

FDA has lifted a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH). “We continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with AIH,” a company release says. “We look forward to engaging with the FDA to align on the design of the next clinical trial of zetomipzomib in AIH.”

Meanwhile, Kezar says that it suspended development of zetomipzomib in lupus nephritis (LN) to focus on AIH, adding that it met with the independent data monitoring committee (IDMC) for the previously terminated PALIZADE clinical trial to review the safety profile of zetomipzomib. “The IDMC has provided Kezar with recommendations for conducting future clinical trials in LN,” it says. “Based on this feedback and internal analysis of safety data across all clinical studies involving zetomipzomib, Kezar plans to respond to the FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in LN.”

Kezar describes zetomipzomib as a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. “Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression,” it says.

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