– Two scientific poster presentations at EASL 2023 will detail findings of Mallinckrodt's latest research providing insight into the therapeutic effect of TERLIVAZ® from baseline, and the clinical management of adults with HRS with rapid reduction in kidney function1 –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (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.
Additionally, results from a pooled analysis from three North American placebo-controlled Phase III trials (OT-0401, REVERSE, CONFIRM) of terlipressin in patients with HRS-1 will be presented by Prof.
Additional information on these studies can be found below.
"We look forward to sharing data on the real-world impact of TERLIVAZ® through the lens of patients with precipitating factors, as well as the potential impact that applying the updated diagnostic criteria can have on improving the timely diagnosis of HRS patients and earlier treatment with available therapies, such as TERLIVAZ.3,4" said
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Poster 1139: Earlier diagnosis of hepatorenal syndrome-acute kidney injury with updated guidelines – review of the CONFIRM trial3
Poster 22: The effect of precipitating factors for hepatorenal syndrome on response to terlipressin treatment: A subgroup analysis of a pooled North American database4
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 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.5,6 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.7
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 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: 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
Senior Vice President,
Global Corporate Controller & Chief Investor Relations Officer
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-2300304 06/23
1 TERLIVAZ® (terlipressin) for injection. [Prescribing Information].
3 Frederick RT, Wong F, Vargas HE, Pappas SC, Jamil K. Earlier diagnosis of hepatorenal syndrome-acute kidney injury with updated guidelines – review of the CONFIRM trial. Abstract to be presented at the
4 Moore K, Zafar Z, Pyrsopoulos NT, Jamil K. The effect of precipitating factors for hepatorenal syndrome on response to terlipressin treatment: A subgroup analysis of a pooled North American database. Abstract to be presented at the
5 C Pant, B S Jani, M Desai, A Deshpande,
7 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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