(RTTNews) - 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.
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