FDA Investigates Kezar Life Sciences' Clinical Hold on Lupus Nephritis Candidate

Monday, 7 October 2024, 01:50

FDA has taken action on Kezar Life Sciences' clinical trial following significant patient deaths. This move raises concerns regarding the safety of the drug under development. Kezar's lead candidate, aimed at lupus nephritis, now faces urgent scrutiny as the agency places it on clinical hold.
Benzinga
FDA Investigates Kezar Life Sciences' Clinical Hold on Lupus Nephritis Candidate

FDA has placed Kezar Life Sciences' lupus nephritis drug on clinical hold due to patient fatalities during the trial. This decision draws attention to the safety and efficacy of clinical trials in the biotech sector.

Background of the Situation

The recent hold was implemented after four reported fatalities in the PORTOLA trial, raising alarms about the viability of Kezar's candidate as a treatment option.

Reactions from Leadership

Chris Kirk, Kezar’s CEO, mentioned in their second-quarter earnings call that thorough investigations are underway to address the adverse events.


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.


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