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针对狼疮的Kezar zetomipzutin IND被FDA临床搁置
2024-10-05 05:50
- Kezar Life Sciences (NASDAQ:KZR) said the FDA has placed a clinical hold on its Investigational New Drug application for zetomipzomib for the treatment of lupus nephritis.
- The hold comes after Kezar informed the agency that it has suspended enrollment and dosing for its Phase 2b PALIZADE study of the drug following a review by the Independent Data Monitoring Board, which included an assessment of four fatal, Grade 5 Serious Adverse Events that occurred during the trial with patients enrolled in Argentina and the Philippines.
- Kezar said the hold does not affect its IND for zetomipzomib in the treatment of autoimmune hepatitis. It added that a Phase 2a study of the drug for that indication has not observed any Grade 4 or 5 SAEs to date, according to a statement.
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