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."