– Findings from two clinical studies and one health economic database analysis provide insight into HRS treatment outcomes with TERLIVAZ,1 patients' cardiac health2 and association between hospital size and overall outcomes for chronic liver disease patients3 –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,4 an acute and life-threatening condition requiring hospitalization.5 TERLIVAZ is not approved in
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
Paul J. Thuluvath, MD, will present findings from a pooled analysis of Mallinckrodt's three prospective, randomized, placebo-controlled clinical studies in patients with HRS (OT-0401, REVERSE, and CONFIRM) to examine whether there was any impact of race (White vs. non-White) on treatment response to TERLIVAZ.1 HRS reversal – defined as the proportion of patients achieving a serum creatinine level of ≤ 1.5 mg/dL while on treatment including up to 24 hours after the last dose of study drug – was examined by race and assessed for the potential to predict treatment response.1
A post-hoc analysis of the Phase III CONFIRM trial – which evaluated maximum change and time of maximum change in mean arterial pressure (MAP), heart rate (HR) and systolic and diastolic blood pressure (SBP and DBP) with TERLIVAZ treatment – will be presented by
Additionally, results from a real-world analysis of the impact of hospital size on patient outcomes among those with chronic liver disease (CLD) and acute kidney injury or HRS will be presented by
Additional information on these studies can be found below.
"These data presentations not only deepen our understanding of how HRS patient baseline characteristics – and their response to therapy – impact treatment outcomes with TERLIVAZ, but also lend insight into how the critical care setting in which patients are hospitalized affects their treatment journey in the real world,"1,2,3 said
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
#P0995: The Effect of Race on Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome: A Pooled Analysis of 3 Phase III Clinical Studies1
#P2399: The Effect of Terlipressin on Blood Pressure, Mean Arterial Pressure, and Heart Rate in Patients with Hepatorenal Syndrome: A Post Hoc Analysis of the CONFIRM Study2
#P0938: Differences in Patient Characteristics and Outcomes by Hospital Size for Patients with Chronic Liver Disease and Acute Kidney Injury or Hepatorenal Syndrome3
Data collected in a retrospective analysis may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
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 function4 is an acute and life-threatening condition that occurs in people with advanced liver disease.5 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.5 HRS involving rapid reduction in kidney function4 is estimated to affect between 30,000 and 40,000 Americans annually.6,7 If left untreated, HRS with rapid reduction in kidney function4 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.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
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-2300746 10/23
1 Thuluvath PJ, et al. The Effect of Race on Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome: A Pooled Analysis of 3 Phase III Clinical Studies. Poster to be presented at the
2 O'Leary JG, et al. The Effect of Terlipressin on Blood Pressure, Mean Arterial Pressure, and Heart Rate in patients with Hepatorenal Syndrome: A Post-Hoc Analysis of the CONFIRM Study. Poster to be presented at the
3 Wong RJ, et al. Differences in Patient Characteristics and Outcomes by Hospital Size for Patients with Chronic Liver Disease and Acute Kidney Injury or Hepatorenal Syndrome. Poster to be presented at the
4 TERLIVAZ® (terlipressin) for injection. Prescribing Information.
6 C Pant, B S Jani, M Desai, A Deshpande,
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