Drugs

Kezar Suspends Lupus Trial After 4 Deaths

Following four fatalities, Kezar Life Sciences has suspended the enrollment of new patients and dosing of ongoing patients in its Phase 2b PALIZADE trial evaluating two dose levels of zetomipzomib (30mg and 60mg) in patients with active lupus nephritis.

The suspension resulted from a safety data review by an independent data monitoring committee (IDMC) that involved emerging safety data, including an assessment of the four Grade 5 (fatal) serious adverse events involving patients enrolled in the Philippines and Argentina, according to the company. “Review of the data by the IDMC revealed that three of the fatalities showed a common pattern of symptoms and proximity to dosing, and additional non-fatal SAEs showed a similar proximity to dosing,” it says. The trial remains blinded and Kezar says it has not observed any instances of death or serious opportunistic infections in prior clinical studies.

To date, 84 patients have been enrolled in the PALIZADE trial, Kezar says, adding that the ongoing Phase 2a PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis has completed enrollment and remains active at this time. To date, no Grade 4 or 5 adverse events have been observed in the PORTOLA study.

The company says it has notified all study investigators and is notifying regulatory authorities, including FDA.

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