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US FDA puts Kezar Life Sciences' lupus treatment trial on hold after patient deaths
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US FDA puts Kezar Life Sciences' lupus treatment trial on hold after patient deaths
Oct 4, 2024 11:13 PM

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.

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