Mallinckrodt (MNK) Presents New Data on TERLIVAZ

Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ^® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.^1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,² an acute and life-threatening condition requiring hospitalization.³ HRS involving rapid reduction in kidney function² is estimated to affect more than 42,000 Americans annually and rates of HRS hospitalizations are increasing.⁴

Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

The post hoc analysis evaluated the efficacy of TERLIVAZ in a subgroup of patients from the CONFIRM trial with HRS, acute-on-chronic liver failure (ACLF) grade 0–2 and serum creatinine (SCr) <5 mg/dL.¹ The incidence of verified HRS reversal – defined as two consecutive SCr values ≤1.5 mg/dL at least two hours apart while on treatment and alive without renal replacement therapy (RRT) for at least 10 days – and HRS reversal – defined as SCr ≤1.5 mg/dL while on treatment – were assessed.¹

"We are pleased to share the latest data providing valuable insight into the relationship between TERLIVAZ treatment and rates of verified HRS reversal in adult cirrhosis patients with AH compounded by HRS," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. "This research is a reflection of our commitment to provide healthcare providers with the most up-to-date clinical information to support critically ill patients, especially those with AH, and drive the importance of early recognition and treatment of HRS at lower SCr levels and ACLF grades for potentially better outcomes."

A total of 117 patients in the subgroup analysis (N=300) met the criteria for evaluation (TERLIVAZ n=78; placebo n=39).¹ The analysis found that the incidence of verified HRS reversal was significantly higher in patients treated with TERLIVAZ vs. placebo (TERLIVAZ: 32%, n=25; placebo: 8%, n=3: p=0.004), as well as the incidence of HRS reversal (TERLIVAZ: 37%, n=29; placebo: 10.3%, n=4: p=0.002).¹

This study was sponsored by Mallinckrodt Pharmaceuticals. Presentation details can be found below:

Abstract #1311: Terlipressin Improves Outcomes in Patients with HRS and Alcoholic Hepatitis: The CONFIRM Study¹

• Presenter: Jody C. Olson, MD, FACP, Department of Internal Medicine, Mayo Clinic, Rochester, MN
• Presentation Date: Monday, January 22, 2024; 2:30 – 3:30 p.m. MT
• Location: Connections Central – RST 04

INDICATION AND LIMITATION OF USE

TERLIVAZ^® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

• Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

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