(Automated translation by Reuters, please see disclaimer
The Food and Drug Administration (FDA) has suspended Kezar Life Sciences KZR.O’s clinical trial of an experimental lupus drug, the company announced Friday.
The FDA’s decision comes after the company said it had paused the mid-stage trial of the drug, zetomipzomib, to review safety data following the deaths of four patients, who were part of the trial. trial in the Philippines and Argentina.
Kezar was testing the drug in patients with active lupus nephritis, which causes inflammation and kidney damage due to a form of immune disease called lupus.
An independent study committee had recommended stopping the trial, after finding that three of the deaths had a common pattern of symptoms and that the deaths occurred close to the time of drug administration, while one Non-fatal adverse event also had similar proximity to time of drug administration.
The company said a separate interim trial testing zetomipzomib in patients with autoimmune hepatitis remains active and no serious adverse events have been reported so far.
