FDA Approves Mallinckrodt's Terlivaz For Injection For Treatment Of Hepatorenal Syndrome
Mallinckrodt plc (MNKPF) said that the U.S. Food and Drug Administration approved Terlivaz (terlipressin) for injection.
The company noted that the Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Terlivaz is expected to be available in the U.S. in the coming weeks.
The FDA approval was based on results from the Phase 3 CONFIRM trial, the largest-ever prospective study conducted to assess the safety and efficacy of terlipressin in patients with HRS type 1 (HRS-1) in the U.S. and Canada. The CONFIRM trial met its primary endpoint of Verified HRS Reversal, defined as renal function improvement, avoidance of dialysis and short-term survival.
SEP 15, 2022
