Kezar Life Sciences Announces Clinical Hold of Zetomipzomib IND for Treatment of Lupus Nephritis (Businesswire) - Oct 4, 2024 - "Kezar Life Sciences...announced that it was informed via teleconference with the U.S. Food and Drug Administration (FDA) that the zetomipzomib Investigational New Drug (IND) application for the treatment of lupus nephritis (LN) has been placed on clinical hold. This action follows Kezar's communication to the FDA that Kezar was voluntarily suspending enrollment and dosing in its Phase 2b PALIZADE clinical trial of zetomipzomib in patients with active LN at the recommendation of the trial's Independent Data Monitoring Committee (IDMC)....The FDA indicated that they will provide an official clinical hold letter to Kezar within 30 days....'At this time, our zetomipzomib IND for the treatment of autoimmune hepatitis is unaffected'."
FDA event • Autoimmune Hepatitis • Lupus Nephritis
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