FDA Halts Kezar’s Lupus Nephritis Trial Due to Safety Concerns Following Four Patient Deaths

Clinical Hold:
The FDA has placed a clinical hold on Kezar Life Sciences' Phase 2b trial of zetomipzomib for lupus nephritis due to safety concerns following the deaths of four patients in the trial.

Patient Deaths:
The deaths occurred in patients participating in the PALIZADE trial in the Philippines and Argentina, with three of the fatalities showing a common pattern of symptoms and proximity to dosing.

Voluntary Suspension:
Kezar voluntarily suspended enrollment and dosing in the PALIZADE trial after the deaths were reported and before the FDA's clinical hold.

Ongoing Investigation:
Kezar is investigating the cases and working on potential risk mitigation strategies for zetomipzomib.

Unaffected Trials:
The clinical hold does not affect Kezar's Phase 2a PORTOLA trial of zetomipzomib for autoimmune hepatitis, which remains active with no reported Grade 4 or 5 serious adverse events.

Regulatory Action:
The FDA will issue an official clinical hold letter to Kezar within the next 30 days.