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US committee backs terlipressin approval for HRS-1

A US FDA advisory committee has voted in favour of approving Dublin, Ireland-based biopharma Mallinckrodt's terlipressin for Hepatorenal Syndrome Type 1 (HRS-1).


HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis, which can be challenging to diagnose in a timely manner.

If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80% mortality within three months.

Terlipressin is a vasopressin analogue which, in clinical trials, was shown to be effective at HRS-1 reversal, which includes three components: renal function improvement, avoidance of dialysis and short-term survival.

"Terlipressin plus albumin is the recommended standard-of-care therapy for HRS-1 in many other countries, where terlipressin is approved," said Francois Durand, on behalf of the International Club of Ascites.

"HRS-1 is one of the most severe complications of end stage liver disease and the favourable vote from the advisory committee is encouraging to US patients in need of treatment."

16th July 2020


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