FDA Puts Kezar Life Sciences' Clinical Trials on Hold Due to Patient Safety Issues
FDA Action on Kezar Life Sciences
The FDA has taken a critical step in investigating Kezar Life Sciences, putting their lead drug candidate for lupus nephritis on clinical hold after a concerning string of patient fatalities.
Details of the Clinical Hold
- Kezar Life Sciences faces scrutiny following four reported patient deaths during their PORTOLA trial.
- The FDA cited concerns over Grade 4 and 5 serious adverse events (SAEs) as a reason for the hold.
- CEO Chris Kirk addressed the issue in the second-quarter earnings report, emphasizing patient safety.
Impact on the Biotech Landscape
This decision is reflective of the FDA's stringent safety monitoring protocols and raises questions about the future of the drug's development.
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