FDA halts Kezar lupus nephritis drug trial

Kezar Life Sciences has revealed that the U.S. Food and Drug Administration (FDA) has imposed a clinical hold on its experimental drug zetomipzomib, intended for the treatment of lupus nephritis. This decision comes after Kezar had already voluntarily paused participant enrollment in its phase 2b PALIZADE trial. The halt followed a review by the Independent Data Monitoring Committee (IDMC), which examined safety data that included four deaths among patients from the Philippines and Argentina.

Despite this setback in the lupus nephritis program, Kezar has assured that the clinical trial of zetomipzomib for autoimmune hepatitis is proceeding as planned. The phase 2a PORTOLA study for autoimmune hepatitis has not reported any severe adverse events, indicating that this particular study remains unaffected by the current issues facing the lupus nephritis trial.

The FDA is expected to send an official clinical hold letter within the next 30 days, providing more detailed information about the hold's implications and requirements for resuming the trial, if possible.

Lupus nephritis, a serious complication that arises from systemic lupus erythematosus, continues to be a difficult condition to manage due to limited treatment options.