US FDA Holds Lupus Trial Due to Patient Deaths

Monday, 7 October 2024, 03:46

US FDA holds lupus trial after patient deaths, as Kezar Life Sciences pauses the Phase IIb PALIZADE trial for zetomipzomib. The pause is in response to serious safety concerns raised by the deaths of four patients. This article delves into the implications of this hold on lupus nephritis treatment options and ongoing research.
Thepharmaletter
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.

Disclaimer: The information provided on this site is for informational purposes only and is not intended as medical advice. We are not responsible for any actions taken based on the content of this site. Always consult a qualified healthcare provider for medical advice, diagnosis, and treatment. We source our news from reputable sources and provide links to the original articles. We do not endorse or assume responsibility for the accuracy of the information contained in external sources.

This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


Related posts


Newsletter

Subscribe to our newsletter for the latest and most reliable health updates. Stay informed and enhance your wellness knowledge effortlessly.

Subscribe