Kezar's Zetomipzomib Faces Second FDA Hold Amid Trials for Autoimmune Diseases

Kezar Life Sciences faces further challenges as the FDA imposes a partial clinical hold on the Phase IIa PORTOLA trial of zetomipzomib, targeting autoimmune hepatitis. This move prevents certain participants from transitioning to the open-label extension, although those in the double-blind treatment period (DBTP) are permitted to complete the 24-week duration, with existing participants in the extension allowed to continue[1]. The FDA's decision follows last month's full hold on the PALIZADE trial for lupus nephritis due to safety concerns, including patient fatalities, raising alarms about the potential risks for placebo recipients starting zetomipzomib[2]. Despite these setbacks, Kezar remains focused on advancing the PORTOLA trial, underscoring the absence of approved therapies for autoimmune hepatitis and striving to address the noted safety concerns.