(Reuters) -The US Food and Drug Administration has clinically suspended Kezar Life Sciences (NASDAQ:)' trial of an experimental lupus drug, the company said 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 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 had recommended a pause in the trial, after finding that three of the deaths showed a common pattern of symptoms and the deaths occurred close to the time of dosing, while one non-fatal adverse event also showed a similar proximity. at the dosing time.
The company said a separate mid-stage trial testing zetomipzomib in patients with autoimmune hepatitis remains active and no serious adverse events have been reported so far.
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