✅   FDA puts Kezar lupus trial on hold after earlier report of patient deaths

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Kezar Life Sciences’ autoimmune drug candidate has been put on hold by the FDA after the company said last week that four patients died in a Phase 2b lupus nephritis trial. The patients were in the Philippines and Argentina, and died after treatment with the company’s drug zetomipzomib. Three of the people shared “a common pattern of symptoms and proximity to dosing,” according to Kezar. Other patients with a “similar proximity to dosing” had serious but non-fatal side effects. Kezar said it expected an update from the FDA within 30 days. Chris Kirk “We are steadfastly committed to patient safety and have directed our efforts to investigate these cases as we look to continue the zetomipzomib development ...

Endpoints     Oct 07, 2024