(Reuters) – The US Food and Drug Administration imposed a clinical suspension on the drug Kezar Life Sciences (NASDAQ:)’ trial of an experimental drug for lupus, the company said Friday.
The FDA’s decision comes after the company said it had temporarily halted a mid-stage trial of the drug, zetomipzomib, to review safety data after the deaths of four patients, who were part of the trial in the Philippines and Argentina.
Kezar was testing the drug in patients with active lupus nephritis, which causes inflammation and damage to the kidneys due to a form of immune-related condition called lupus.
An independent study committee recommended pausing the trial after finding that three of the deaths showed a common pattern of symptoms and that the deaths occurred close to the time of dosing, while a non-fatal adverse event also showed a similar close to the time of dosing. Dosing time.
A separate mid-stage trial testing zetomibzomib in patients with autoimmune hepatitis remains active and no serious adverse events have been reported to date, the company said.