Oct 4 (Reuters) - The U.S. Food and Drug Administration
has placed a clinical hold on Kezar Life Sciences' ( KZR ) trial
of experimental drug for lupus, the company said on 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 in the kidneys
due to a form of immune-related condition called lupus.
An independent study committee had recommended a pause on
the trial, after it found that three of the fatalities showed a
common pattern of symptoms and the deaths happened close to the
time of dosing, while a non-fatal adverse event also showed a
similar proximity to the dosing time.
The company said that a separate mid-stage trial testing
zetomipzomib in patients with autoimmune hepatitis remains
active and no serious adverse events have been reported so far.