US FDA Holds Lupus Trial Due to Patient Deaths
US FDA Holds Lupus Trial Following Fatalities
The US FDA has taken significant action by placing a hold on the lupus trial conducted by Kezar Life Sciences.
The Phase IIb PALIZADE trial for zetomipzomib in lupus nephritis has been paused after troubling reports of patient deaths.
Background on the Trial
This trial involved 84 patients, who were being evaluated for the efficacy of zetomipzomib.
Unfortunately, four patient deaths have raised safety alarms, prompting the FDA's immediate oversight.
Implications for Lupus Nephritis Treatment
The halt in the trial raises critical concerns about the safety of new treatments for lupus nephritis, a condition that severely affects kidney function.
As researchers and healthcare providers grapple with this situation, the future of lupine therapeutic interventions remains uncertain.
- Safety First: The safety of participants is paramount in clinical trials.
- Considering Alternatives: Patients may need to explore additional treatment options during this pause.
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