– 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 –
DUBLIN, Nov. 3, 2022
/PRNewswire/ -- Mallinckrodt
plc (NYSE American: MNK), a global specialty pharmaceutical
company, today announced that seven scientific abstracts on
clinical and health economic outcomes research on treatment with
TERLIVAZ® (terlipressin) for adult patients with
hepatorenal syndrome (HRS) involving rapid reduction in kidney
function,1 an acute and life-threatening condition
requiring hospitalization2 will be presented at the
American Association for the Study of Liver Diseases (AASLD) 2022
Liver Meeting in Washington, DC,
from November 4-8. TERLIVAZ is the
first and only FDA-approved product indicated to improve kidney
function in adults with hepatorenal syndrome
(HRS).1
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. Ethan Weinberg,
University of Pennsylvania,
Philadelphia, PA, examined
long-term clinical outcomes of terlipressin-treated patients with
HRS type 1 (HRS-1) who received a liver transplant compared with
those who received placebo.3 Furthermore, an interim
analysis of the INFUSE study examining the investigational use of
continuous terlipressin infusion for patients with HRS acute kidney
injury (AKI-HRS) was selected as an "AASLD Presidential Poster
of Distinction," to be presented by Dr. K. Rajender Reddy, University
of Pennsylvania Perelman School of Medicine, Division of
Gastroenterology and Hepatology, Philadelphia, PA.4 TERLIVAZ is only
approved for intravenous (IV) bolus dosing.1
Additional information on Dr. Weinberg's and Dr. Reddy's studies
and the full list of Mallinckrodt's
presentations can be found below.
"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 U.S., and the need for additional options," said
Khurram Jamil, Vice President,
Hepatology, Clinical Development & Critical Care. "In light
of the recent FDA approval of TERLIVAZ, and exemplified through our
ongoing research efforts, Mallinckrodt's commitment to improving treatment
outcomes in HRS remains strong, and we are hopeful that we are one
step closer to addressing the unmet needs of critically ill patient
populations."
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
- Presenter: Ethan
Weinberg, MD, MS
- Presentation Date: November 7,
2022; 9:15AM ET
- Location: Room 202, Walter E. Washington Convention
Center
*SELECTED AS "BEST OF LIVER MEETING"
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
- Presenter: Ethan
Weinberg, MD, MS
- Presentation Date: November 7,
2022; 10:15 AM ET
- Location: Room 202, Walter E. Washington Convention
Center
Abstract 3703: Partial Response to Terlipressin Therapy, as
per International Club of Ascites (ICA) Criteria, is Associated
with a Lower End-of-treatment Acute-on-chronic Liver Failure Grade
and Fewer Organ Failures in Patients with Hepatorenal Syndrome Type
1 (HRS)6
- Presenter: Florence Wong,
MD
- Presentation Date: November 6,
2022; 1:00 PM ET
- Location: Poster Hall, Hall E, Walter E. Washington
Convention Center
Abstract 3656: Safety and Efficacy of Continuous Infusion
Terlipressin in AKI-HRS: The INFUSE
Study4
- Presenter: K. Rajender
Reddy, MD, FAASLD
- Presentation Date: November 6,
2022; 1:00 PM ET
- Location: Poster Hall E, Walter E. Washington Convention
Center
* AASLD Presidential Poster of Distinction
Abstract 3714: Cost Per Response with Terlipressin Versus
Standard of Care in Hepatorenal Syndrome
Patients7
- Presenter: John A.
Carter, MD
- Presentation Date: November 6,
2022; 1:00 PM ET
- Location: Poster Hall, Hall E, Walter E. Washington
Convention Center
Abstract 3719: Real-world Patient Characteristics, Treatment,
and Outcomes for Hepatorenal Syndrome: Evidence from the U.S. and
UK Medical Chart Studies8
- Presenter: Andrew S.
Allegretti, MD
- Presentation Date: November 6,
2022; 1:00 PM ET
- Location: Poster Hall, Hall E, Walter E. Washington
Convention Center
Abstract 3699: Retrospective Analysis of Treatment Response
in Patients with Hepatorenal Syndrome/Acute Kidney Injury
(HRS-AKI): Real-world Evidence from
2016-20209
- Presenter: Xingyue Huang,
PhD
- Presentation Date: November 6,
2022; 1:00 PM ET
- Location: Poster Hall, Hall E, Walter E. Washington
Convention Center
Find more information on the American Association for the Study
of Liver Diseases (AASLD) 2022 Liver Meeting Website.
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 U.S. for more than 30 years and is available
on five continents for its indications in the countries where it is
approved.11,12
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.
- Patients with a serum creatinine >5 mg/dL are unlikely to
experience benefit.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
- TERLIVAZ may cause serious or fatal respiratory failure.
Patients with volume overload or with acute-on-chronic liver
failure (ACLF) Grade 3 are at increased risk. Assess oxygenation
saturation (e.g., SpO2) before initiating
TERLIVAZ.
- Do not initiate TERLIVAZ in patients experiencing hypoxia
(e.g., SpO2 <90%) until oxygenation levels improve.
Monitor patients for hypoxia using continuous pulse oximetry during
treatment and discontinue TERLIVAZ if SpO2 decreases
below 90%.
Contraindications
TERLIVAZ is contraindicated:
- In patients experiencing hypoxia or worsening respiratory
symptoms.
- In patients with ongoing coronary, peripheral, or mesenteric
ischemia.
Warnings and Precautions
- Serious or Fatal Respiratory Failure: Obtain baseline
oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
Monitor patients for changes in respiratory status using continuous
pulse oximetry and regular clinical assessments. Discontinue
TERLIVAZ in patients experiencing hypoxia or increased respiratory
symptoms.
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.
- Ineligibility for Liver
Transplant: TERLIVAZ-related adverse reactions
(respiratory failure, ischemia) may make a patient ineligible for
liver transplantation, if listed. For patients with high
prioritization for liver transplantation (e.g., MELD ≥35), the
benefits of TERLIVAZ may not outweigh its risks.
- Ischemic Events: TERLIVAZ may cause cardiac,
cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of
TERLIVAZ in patients with a history of severe cardiovascular
conditions or cerebrovascular or ischemic disease. Discontinue
TERLIVAZ in patients who experience signs or symptoms suggestive of
ischemic adverse reactions.
- Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm
when administered to a pregnant woman. If TERLIVAZ is used during
pregnancy, the patient should be informed of the potential risk to
the fetus.
Adverse Reactions
- The most common adverse reactions (≥10%) include abdominal
pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please click here to see full Prescribing Information,
including Boxed Warning.
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. 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.
CONTACT
Media Inquiries
Heather
Guzzi
Senior Vice President, Green Room Communications
973-524-4112
hguzzi@greenroompr.com
Investor Relations
Daniel J.
Speciale
Global Corporate Controller & Chief Investor Relations
Officer
314-654-3638
daniel.speciale@mnk.com
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
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
References
1 TERLIVAZ® (terlipressin) for injection
[prescribing information]. Mallinckrodt Hospital Products Inc.
2 National Organization for Rare Disorders. Hepatorenal
Syndrome. Available
at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/.
Accessed October 20, 2022.
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 American
Association for the Study of Liver Diseases (AASLD) 2022 Liver
Meeting. November 2022.
4 Reddy KR. Safety and Efficacy of Continuous Infusion
Terlipressin in AKI-HRS: The INFUSE Study. To be
Presented at the American Association for the Study of Liver
Diseases (AASLD) 2022 Liver Meeting. November 2022.
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 American Association for
the Study of Liver Diseases (AASLD) 2022 Liver Meeting.
November 2022.
6 Wong F. Partial Response to Terlipressin Therapy, as
per International Club of Ascites (ICA) Criteria, is Associated
with a Lower End-of-treatment Acute-on-chronic Liver Failure Grade
and Fewer Organ Failures in Patients with Hepatorenal Syndrome Type
1 (HRS). To be Presented at the American Association for
the Study of Liver Diseases (AASLD) 2022 Liver Meeting.
November 2022.
7 Carter JA. Cost Per Response with Terlipressin Versus
Standard of Care in Hepatorenal Syndrome Patients. To be
Presented at the American Association for the Study of Liver
Diseases (AASLD) 2022 Liver Meeting. November 2022.
8 Allegretti AS. Real-world Patient Characteristics,
Treatment, and Outcomes for Hepatorenal Syndrome: Evidence from the
U.S. and UK Medical Chart Studies. To be Presented at the
American Association for the Study of Liver Diseases (AASLD) 2022
Liver Meeting. November 2022.
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 American Association for the Study of Liver
Diseases (AASLD) 2022 Liver Meeting. November 2022.
10 Data on File – Ref-05488. Mallinckrodt
Pharmaceuticals.
11 Data on File – Ref-05482. Mallinckrodt
Pharmaceuticals.
12 FDA Cardiovascular and Renal Drugs Advisory
Committee. Mallinckrodt Pharmaceuticals Terlipressin Advisory
Committee Briefing Document NDA #022231. July 2020.
13 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan
Taylor, R Gilroy, M OIyaee. Hepatorenal syndrome in
hospitalized patients with chronic liver disease: results from the
Nationwide Inpatient Sample 2002-2012. J of Investig Med.
2016; 64:33-38.
14 United States Census Bureau: Quick Facts. Available
at: https://www.census.gov/quickfacts/fact/table/US/PST045218.
Accessed October 20, 2022.
15 Flamm SL, Brown K, Wadei HM., et al. The Current
Management of Hepatorenal Syndrome–Acute Kidney Injury in
the United States and the
Potential of Terlipressin. Liver Transpl.
2021;27:1191-1202. https://doi.org/10.1002/lt.26072.
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