Kezar Life Sciences has announced that the FDA has placed a clinical hold on its investigational drug zetomipzomib for the treatment of lupus nephritis.
The decision follows Kezar's voluntary suspension of enrollment in its phase 2b PALIZADE trial after the Independent Data Monitoring Committee (IDMC) reviewed safety data, including four fatal adverse events in patients from the Philippines and Argentina.
Despite the hold on the lupus nephritis program, Kezar confirmed that the zetomipzomib trial for autoimmune hepatitis remains unaffected, with no severe adverse events reported in the phase 2a PORTOLA study. The FDA will issue an official clinical hold letter within 30 days.
Lupus nephritis, a severe complication of systemic lupus erythematosus, remains a challenging condition with limited treatment options.
