–Three scientific abstracts via one oral and two poster presentations detail the Company's latest clinical research findings on the therapeutic effect of TERLIVAZ for adults with HRS involving rapid reduction in kidney function1 –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
Mallinckrodt's three scientific abstracts at ASN's Kidney Week 2023 Scientific Meeting, two of which will take place on
A pooled analysis of the results from the three largest prospective, randomized, placebo-controlled clinical studies in patients with HRS (OT-0401, REVERSE, and CONFIRM) will be presented by Hani M. Wadei, MD.4 The analysis assessed the role of TERLIVAZ plus albumin versus placebo plus albumin on HRS reversal in the subpopulation of patients with comorbidities of alcoholic hepatitis, mean arterial pressure of <70 mmHg and/or systemic inflammatory response syndrome.4
In an oral presentation, Hani M. Wadei, MD, will also present a post hoc analysis of the Phase III, randomized, placebo-controlled CONFIRM study evaluating the incidence, indications, and modes of renal replacement therapy used in the subgroup of patients with fluid overload, as determined by investigator assessment.5 Patients with fluid overload included those who reported hemodynamic edema and effusions.5
Additional information on these studies can be found below.
"The CONFIRM clinical trial was the largest-ever prospective, randomized clinical trial of TERLIVAZ in patients with hepatorenal syndrome (HRS),1 and continues to offer new learnings and insights as reflected in the upcoming presentations at the
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
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
Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
Please click here to see full Prescribing Information, including Boxed Warning.
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 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.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.6,7 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.8
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; cultured skin substitutes 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.
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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, and its potential impact on patients. 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 impact of Mallinckrodt's pending Chapter 11 cases; 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
Senior Vice President, Finance and Chief Financial Officer, Specialty Generics
Vice President, Investor Relations
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2023 Mallinckrodt. US-2300739 11/23
1 TERLIVAZ® (terlipressin) for injection. [Prescribing Information].
3 Velez JCQ, Mujtaba MA, Zhiwei Z, Elsiesy H, Jamil K. Improvement in Serum Creatinine was Associated with Favorable Clinical Outcomes in Patients with Hepatorenal Syndrome: A Post Hoc Analysis of the CONFIRM Study. Abstract to be presented at the
4 Wadei HM, Zhang Z, Alzubaidl M, Jamil K. Terlipressin Therapy in Patients with HRS and Comorbidities: The North American Experience. Abstract to be presented at the
5 Wadei HM, Mujtaba MA, Jamil K. Effect of Terlipressin Treatment on the Incidence of Renal Replacement Therapy in Patients with Hepatorenal Syndrome and Fluid Overload: A Post Hoc Analysis of the Phase 3 CONFIRM Study. Abstract to be presented at the
6 Data on file – Ref-06931. Mallinckrodt Pharmaceuticals.
7 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
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