– Three scientific abstracts highlighting clinical research of terlipressin treatment for adults with HRS involving rapid reduction in kidney function1 will be presented at the ASN Scientific Meeting, reinforcing Mallinckrodt's ongoing commitment to critically ill patients –
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
The findings from a pooled analysis across the OT-0401, REVERSE, and CONFIRM clinical trials, presented by Dr.
"We are eager to share data from our latest studies assessing treatment paradigms in the management of HRS and examining the clinical benefits of patients treated with terlipressin among the broader healthcare professional community. These findings provide critical insight into the importance of patient characteristics at baseline and reducing the time to therapeutic intervention in potentially improving long-term outcomes and the avoidance of renal replacement therapy, such as dialysis, in adults with HRS," said
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Abstract TH-PO034: Initiation of Terlipressin at Lower Serum Creatinine Levels Is Associated With Avoidance of Dialysis in Patients With Hepatorenal Syndrome Type 13
Abstract TH-PO035: Impact of Terlipressin on Serum Sodium Levels in Patients with HRS – the North American Experience4
Abstract TH-PO037: Impact of HRS Reversal on the Need for Renal Replacement Therapy – Analysis from 3 Phase III Terlipressin Studies5
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.6 It has been approved outside the
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.9,10 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.11
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
TERLIVAZ is contraindicated:
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.
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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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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.
©2022 Mallinckrodt. US-2201045 11/22
1 TERLIVAZ® (terlipressin) for injection [prescribing information].
2 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed October 13, 2022.
3 JC Q. Velez. Initiation of Terlipressin at Lower Serum Creatinine Levels Is Associated With Avoidance of Dialysis in Patients With Hepatorenal Syndrome Type 1. To be Presented at the
4 SN Merwat. Impact of Terlipressin on Serum Sodium Levels in Patients with HRS – the North American Experience. To be Presented at the
5 MA Mujtaba. Impact of HRS Reversal on the Need for Renal Replacement Therapy – Analysis from 3 Phase III Terlipressin Studies. To be Presented at the
6 Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.
7 Data on File – Ref-05482. Mallinckrodt Pharmaceuticals.
8 FDA Cardiovascular and Renal Drugs Advisory Committee. Mallinckrodt Pharmaceuticals Terlipressin Advisory Committee Briefing Document NDA #022231.
9 C Pant, B S Jani, M Desai, A Deshpande,
11 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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SOURCE Mallinckrodt plc