At last, a win for terlipressin -- and Mallinckrodt

Ten years after being rebuffed by FDA and with a failed Phase III trial squeezed in between, Mallinckrodt’s terlipressin finally hit the mark in treating patients with an acute form of kidney failure.

On Thursday, the specialty pharma said terlipressin met the primary endpoint of verified HRS-1 reversal vs. placebo (p=0.012) in the Phase III CONFIRM trial in 300 patients with hepatorenal syndrome Type I (HRS-1). Mallinckrodt plc (NYSE:MNK) said the data would support an NDA submission, expected in early 2020...