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.