HawkInsight

  • Contact Us
  • App
  • English

Kezar zetomipzomib IND for lupus placed on FDA clinical hold

Grandbrothers 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.

Disclaimer: The views in this article are from the original author and do not represent the views or position of Hawk Insight. The content of the article is for reference, communication and learning only, and does not constitute investment advice. If it involves copyright issues, please contact us for deletion.

NewFlashHawk Insight
More