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# Panel Delivers Mixed Vote on Mallinckrodt Kidney Drug
- URL: https://www.fdaweb.com/panel-delivers-mixed-vote-on-mallinckrodt-kidney-drug/
- Published: 2020-07-16T12:00:00.000Z
- Updated: 2026-09-14T16:21:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147216

FDA’s Cardiovascular and Renal Drugs Advisory Committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodt’s terlipressin and its use to treat adults with hepatorenal syndrome (HRS) Type 1\. The acute and life-threatening syndrome involves acute kidney failure in people with cirrhosis. A user fee review action from the agency is expected by 9/12.

In a [briefing document](https://www.fda.gov/media/139963/download?ref=fdaweb.com), FDA reviewers acknowledged that trial data met the primary endpoint of HRS reversal with 29% of patients in the terlipressin arm compared to 16% in the placebo arm achieving verified HRS reversal. However, the briefing document raised safety problems, noting that the percentage of patient deaths was higher in the terlipressin arm compared with the placebo group. Other complications associated with the drug included respiratory failure, sepsis, and septic shock.

The safety concerns were the driving factor in panel members voting not to recommend approval, and other panel members agreed that the benefits outweighed the risks because there are no FDA-approved treatments for HRS Type 1.