– Seven scientific abstracts spanning clinical and health economic outcomes research will be presented at the AASLD Liver Meeting, showcasing the breadth of Mallinckrodt's commitment to HRS patients with rapid reduction in kidney function1 –
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
The findings from a subgroup analysis of the CONFIRM trial, selected as AASLD's "Best of Liver Meeting" abstract, presented by Dr.
Additional information on
"We look forward to sharing our breadth of data across clinical research and treatment paradigms with terlipressin as well as health economic outcomes assessments uncovering the associated economic and healthcare resource burden for healthcare systems and patients with HRS with rapid reduction in kidney function.1 These findings not only provide valuable insight into the association between patient characteristics and long-term treatment outcomes, but also help to highlight the inherent clinical and economic burden HRS patients and providers face in the
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Abstract 164: Pretransplant Terlipressin Treatment for Hepatorenal Syndrome Decreases the Need for Renal Replacement Therapy both Pre- and Posttransplant: A 12-month Follow-up Analysis of the CONFIRM Trial3
Abstract 163: Rebound in Serum Creatinine Levels After Terlipressin-based Treatment of Patients with Acute Kidney Injury-Hepatorenal Syndrome (HRS-AKI) is Uncommon Over the Short Term in Patients with a Complete Response: Results from the CONFIRM Study5
Abstract 3703: Partial Response to Terlipressin Therapy, as per
Abstract 3656: Safety and Efficacy of Continuous Infusion Terlipressin in AKI-HRS: The INFUSE Study4
Abstract 3714: Cost Per Response with Terlipressin Versus Standard of Care in Hepatorenal Syndrome Patients7
Abstract 3719: Real-world Patient Characteristics, Treatment, and Outcomes for Hepatorenal Syndrome: Evidence from the
Abstract 3699: Retrospective Analysis of Treatment Response in Patients with Hepatorenal Syndrome/Acute Kidney Injury (HRS-AKI): Real-world Evidence from 2016-20209
Find more information on the
Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.10 It has been approved outside the
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 between 30,000 and 40,000 Americans annually.13,14 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.15
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.
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 includes forward-looking statements with regard to TERLIVAZ, including 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: satisfaction of 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; 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 SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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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.
©2022 Mallinckrodt. US-2201067 11/22
1 TERLIVAZ® (terlipressin) for injection [prescribing information].
3 Weinberg E. Pretransplant Terlipressin Treatment for Hepatorenal Syndrome Decreases the Need for Renal Replacement Therapy both Pre- and Posttransplant: A 12-month Follow-up Analysis of the CONFIRM Trial. To be Presented at the
4 Reddy KR. Safety and Efficacy of Continuous Infusion Terlipressin in AKI-HRS: The INFUSE Study. To be Presented at the
5 Weinberg E. Rebound in Serum Creatinine Levels After Terlipressin-based Treatment of Patients with Acute Kidney Injury-Hepatorenal Syndrome (HRS-AKI) is Uncommon Over the Short Term in Patients with a Complete Response: Results from the CONFIRM Study. To be Presented at the
6 Wong F. Partial Response to Terlipressin Therapy, as per
7 Carter JA. Cost Per Response with Terlipressin Versus Standard of Care in Hepatorenal Syndrome Patients. To be Presented at the
8 Allegretti AS. Real-world Patient Characteristics, Treatment, and Outcomes for Hepatorenal Syndrome: Evidence from the
9 Huang X. Retrospective Analysis of Treatment Response in Patients with Hepatorenal Syndrome/Acute Kidney Injury (HRS-AKI): Real-world Evidence from 2016-2020. To be Presented at the
10 Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.
11 Data on File – Ref-05482. Mallinckrodt Pharmaceuticals.
13 C Pant, B S Jani, M Desai, A Deshpande,
15 Flamm SL, Brown K, Wadei HM., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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