– Oral presentation of a post hoc analysis of the Phase 3 CONFIRM trial details the therapeutic effect of TERLIVAZ in adult patients with hepatorenal syndrome (HRS) and alcoholic hepatitis (AH)1 –
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
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
INDICATION AND LIMITATION OF USE
TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
TERLIVAZ is contraindicated:
Warnings and Precautions
Please click here to see full Prescribing Information, including Boxed Warning.
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function2 is an acute and life-threatening condition that occurs in people with advanced liver disease.3 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.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 If left untreated, HRS with rapid reduction in kidney function2 has a median survival time of less than two weeks and greater than 80 percent mortality within three months.5
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, its potential impact on patients, and the planned presentation regarding the TERLIVAZ trial. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
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1 Olson JC, et al. Terlipressin Improves Outcomes in Patients with HRS and Alcoholic Hepatitis: The CONFIRM Study. Oral presentation to be shared at the
2 TERLIVAZ® (terlipressin) for Injection. Prescribing Information.
4 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin K, Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. doi.org/10/1080/07853890.
5 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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SOURCE Mallinckrodt plc