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Mallinckrodt drug improves kidney function in patients with rare liver disease

Mallinckrodt PLC said its treatment for a rare liver disease improved renal function and allowed patients to avoid dialysis during a late-stage study.

The phase 3 trial, named Confirm, compared terlipressin with placebo in 300 adults with hepatorenal syndrome type-1, or HRS-1. The rare disease has no approved therapies in the U.S and Canada.

HRS-1 is characterized by complications of liver disease that lead to kidney failure. More than 80% of the patients with HRS-1 die within three months, according to an Aug. 15 statement by the company.

Terlipressin was found to be effective in producing improvements in kidney function, providing short-term survival and allowing patients to avoid dialysis.

The U.K.-based pharmaceutical company said it plans to submit a new drug application for terlipressin with the U.S. Food and Drug Administration in early 2020.