MALLINCKRODT PLC Included among Mallinckrodt's breadth of data for adults with HRS with rapid reduction in kidney function1 are three oral presentations and one Poster of Distinction detailing research of clinical outcomes with TERLIVAZ2,3,4 and real-world health economics outcomes for TERLIVAZ-treated patients with comorbidities.5
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.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8
'It is essential to continue research into the relationship between TERLIVAZ treatment and key factors impacting clinical outcomes, such as concomitant treatments, comorbidities, and real-world care environments, to provide further insights into the continued use of TERLIVAZ for patients with this critical condition,' said
Highlights of Mallinckrodt's 11 scientific presentations at the AASLD 2023 Liver Meeting include
Three Oral Presentations
Findings from a pooled analysis of the three largest-ever prospective studies to assess the safety and efficacy of TERLIVAZ in patients with HRS type 1 (HRS-1) in the
Health economics outcomes from a decision-analytic model projecting the benefit of TERLIVAZ treatment among patients with alcohol-related cirrhosis and HRS (Abstract #80).5
An analysis of the clinical outcomes associated with concomitant albumin dosing with TERLIVAZ for the treatment of HRS-acute kidney injury (HRS-AKI) (Abstract #211).3
One AASLD Poster of Distinction
Results from a post hoc analysis of the CONFIRM, REVERSE, and OT-0401 trials assessing the relationship between mean arterial pressure and TERLIVAZ in HRS-AKI reversal (Abstract #3052-A).4
Mallinckrodt will also be present at the meeting with an interactive Medical Affairs booth in the exhibit hall (Location D2825) throughout the duration of the meeting.
Data collected in retrospective, pooled, database, or post hoc analyses 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.
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.6 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.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8 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.9,10
ABOUT MALLINCKRODT
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.
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
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
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