(Reuters) -The U.S. Food and Drug Administration has exerted a clinical grip on the situation Kezar life sciences (NASDAQ:)’ study of an experimental drug for lupus, the company said Friday.
The FDA’s decision comes after the company said it had halted its interim 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 tested 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 investigative committee had recommended a pause in the trial after finding that three of the fatalities showed a common pattern of symptoms and that the deaths occurred close to the time of administration, while a non-fatal adverse event also showed similar proximity as the dosing time.
The company said a separate interim trial testing zetomipzomib in patients with autoimmune hepatitis remains active and no serious side effects have been reported to date.
