FDA approved terlipressin injection for hepatorenal syndrome

The U.S. Food and Drug Administration approved terlipressin (Terlivaz; Mallinckrodt) injection. Terlivaz to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1.

This is the only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function.

Approval was based, in part, on results from the Phase 3 CONFIRM trial, including 300 patients with HRS type 1. The CONFIRM trial met its primary endpoint of Verified HRS Reversal, defined as renal function improvement, avoidance of dialysis and short-term survival.

“The FDA approval of Terlivaz is a significant milestone for Mallinckrodt as it brings an important treatment option to these critically ill patients requiring hospitalization and to U.S. physicians who historically have had limited treatment interventions,” said Siggi Olafsson, President and Chief Executive Officer, Mallinckrodt. “We’re excited to bring Terlivaz to U.S. patients and physicians and plan to launch the product in the coming weeks. This approval reflects Mallinckrodt’s continued commitment to underserved patients and their caregivers through our demonstrated expertise and dedication to developing therapeutics for critical conditions.”

Read the full press release here.