–Three scientific abstracts via one oral and two
poster presentations detail the Company's latest clinical research
findings on the therapeutic effect of TERLIVAZ for adults with HRS
involving rapid reduction in kidney function1 –
DUBLIN, Nov. 1, 2023
/PRNewswire/ -- Mallinckrodt
plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical
company, today announced that three scientific abstracts evaluating
treatment with TERLIVAZ® (terlipressin) for injection
for adults with hepatorenal syndrome (HRS) with rapid reduction in
kidney function1 – including its impact on patient
care, key HRS endpoints and patient comorbidity – will be presented
at the American Society of Nephrology (ASN) Kidney Week 2023
Scientific Meeting in Philadelphia,
Pennsylvania, taking place November
2-5, 2023.
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.2
Please see Limitation of Use and Important Safety
Information, including Boxed Warning, below.
Mallinckrodt's three scientific
abstracts at ASN's Kidney Week 2023 Scientific Meeting, two of
which will take place on November 2
and one on November 4, will be
presented by Juan Carlos Q. Velez,
MD, and Hani M. Wadei, MD.
Juan Carlos Q. Velez, MD, will
present findings from a post hoc analysis of the Phase III CONFIRM
clinical trial exploring the incidence of HRS reversal in patients
treated with TERLIVAZ plus albumin versus placebo plus albumin to
determine if an improvement in serum creatinine of >30% was
associated with improved clinical outcomes.3 The
study evaluated the magnitude of improvement in serum creatinine
level from baseline to the end of treatment, and its potential
relationship with patient's length of intensive care unit stay and
the incidence of renal replacement therapy, among other clinical
measures.3
A pooled analysis of the results from the three largest
prospective, randomized, placebo-controlled clinical studies in
patients with HRS (OT-0401, REVERSE, and CONFIRM) will be presented
by Hani M. Wadei, MD.4 The analysis assessed the
role of TERLIVAZ plus albumin versus placebo plus albumin on HRS
reversal in the subpopulation of patients with comorbidities of
alcoholic hepatitis, mean arterial pressure of <70 mmHg and/or
systemic inflammatory response syndrome.4
In an oral presentation, Hani M. Wadei, MD, will also present a
post hoc analysis of the Phase III, randomized, placebo-controlled
CONFIRM study evaluating the incidence, indications, and modes of
renal replacement therapy used in the subgroup of patients with
fluid overload, as determined by investigator
assessment.5 Patients with fluid overload included
those who reported hemodynamic edema and effusions.5
Additional information on these studies can be found below.
"The CONFIRM clinical trial was the largest-ever prospective,
randomized clinical trial of TERLIVAZ in patients with hepatorenal
syndrome (HRS),1 and continues to offer new
learnings and insights as reflected in the upcoming presentations
at the American Society of Nephrology's Annual Meeting," said
Khurram Jamil, Vice President,
Hepatology, Clinical Development & Critical Care. "We're
hopeful these findings will continue to inform the medical
community's approach to diagnosis and clinical management of this
critical condition, leading to better outcomes for HRS patients
with rapid reduction in kidney function."1
These studies are sponsored by Mallinckrodt Pharmaceuticals and
include:
Abstract TH-PO052: Improvement in Serum Creatinine was
Associated with Favorable Clinical Outcomes in Patients with
Hepatorenal Syndrome: A Post Hoc Analysis of the CONFIRM
Study3
- Presenter: Juan Carlos Q.
Velez, MD, Ochsner Health, New
Orleans, LA, USA
- Session Type: Poster Presentation
- Presentation Location: Exhibit Hall, Pennsylvania Convention Center
- Session Date and Time: Thursday, November 2, 2023; 10:00
a.m. – 12:00 p.m. EDT
Abstract TH-PO050: Terlipressin Therapy in Patients with HRS
and Comorbidities: The North American
Experience4
- Presenter: Hani M. Wadei, MD, Mayo Clinic, Jacksonville, FL, USA
- Session Type: Poster Presentation
- Presentation Location: Exhibit Hall, Pennsylvania Convention Center
- Session Date and Time: Thursday, November 2, 2023; 10:00
a.m. – 12:00 p.m. EDT
Abstract SA-OR03: Effect of Terlipressin Treatment on the
Incidence of Renal Replacement Therapy in Patients with Hepatorenal
Syndrome and Fluid Overload: A Post Hoc Analysis of the Phase 3
CONFIRM Study5
- Presenter: Hani M. Wadei, MD, Mayo Clinic, Jacksonville, FL, USA
- Session Type: Oral Presentation
- Presentation Location: Room 118, Pennsylvania Convention Center
- Presentation Date and Time: Saturday, November 4, 2023;
4:48 – 4:57 p.m. EDT
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 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 more than 35,000
Americans annually and rates of HRS hospitalizations are
increasing.6,7 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.8
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 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 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
Green Room Communications
954-816-6003
mediainquiries@grcomms.com
Investor Relations
Daniel J.
Speciale
Senior Vice President, Finance and Chief Financial Officer,
Specialty Generics
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.
©2023 Mallinckrodt. US-2300739 11/23
References
1 TERLIVAZ® (terlipressin) for injection.
[Prescribing Information]. Mallinckrodt Hospital Products Inc.
2023.
2 National Organization for Rare Disorders. Hepatorenal
Syndrome. Available
at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/.
Accessed September 14, 2023.
3 Velez JCQ, Mujtaba MA, Zhiwei Z, Elsiesy H, Jamil K.
Improvement in Serum Creatinine was Associated with Favorable
Clinical Outcomes in Patients with Hepatorenal Syndrome: A Post Hoc
Analysis of the CONFIRM Study. Abstract to be presented at the
American Society of Nephrology (ASN) 2023 Annual meeting.
November 2023.
4 Wadei HM, Zhang Z, Alzubaidl M, Jamil K. Terlipressin
Therapy in Patients with HRS and Comorbidities: The North American
Experience. Abstract to be presented at the American Society of
Nephrology (ASN) 2023 Annual meeting. November 2023.
5 Wadei HM, Mujtaba MA, Jamil K. Effect of Terlipressin
Treatment on the Incidence of Renal Replacement Therapy in Patients
with Hepatorenal Syndrome and Fluid Overload: A Post Hoc Analysis
of the Phase 3 CONFIRM Study. Abstract to be presented at the
American Society of Nephrology (ASN) 2023 Annual meeting.
November 2023.
6 Data on file – Ref-06931. Mallinckrodt
Pharmaceuticals.
7 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin K,
Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from
2008 to 2018. Annals of Med. 2021; 53:1.
doi.org/10/1080/07853890
8 Flamm, S.L., Brown, K., Wadei, H.M., 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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