– 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 –
DUBLIN, Nov. 1, 2022
/PRNewswire/ -- Mallinckrodt
plc (NYSE American: MNK), a global specialty pharmaceutical
company, today announced that three scientific abstracts on
clinical research on treatment with TERLIVAZ®
(terlipressin) for adult patients with hepatorenal syndrome (HRS)
involving rapid reduction in kidney function,1 will
be presented at the American Society of Nephrology (ASN) Kidney
Week 2022 Scientific Meeting in Orlando,
Florida, from November 3-6.
TERLIVAZ is the first and only FDA-approved product indicated to
improve kidney function in adults with hepatorenal syndrome (HRS)
involving 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.
The findings from a pooled analysis across the OT-0401, REVERSE,
and CONFIRM clinical trials, presented by Dr. Juan Carlos Q. Velez, MD, Ochsner Health Network
LLC, New Orleans, Louisiana,
suggest that initiating treatment with terlipressin plus albumin in
patients with HRS Type 1 (HRS-1) at lower serum creatinine (SCr)
levels and Model for End-stage Liver Disease (MELD) scores is
associated with greater probability of avoiding renal replacement
therapy (RRT) through 90 days of treatment.3 Additional
information on Dr. Velez' study and the full list of Mallinckrodt's presentations can be found
below.
"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
Khurram Jamil, Vice President,
Hepatology, Clinical Development & Critical Care.
"Following the recent FDA approval of TERLIVAZ, we are encouraged
by the growing body of evidence that continues to support
Mallinckrodt's commitment to improving
the care for critically ill patients with unmet needs."
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
- Presenter: Juan Carlos Q. Velez, MD
- Presentation Date: November 3, 2022; 10AM – 12PM ET
- Location: Exhibit Hall, Orange
County Convention Center, West Building
Abstract TH-PO035: Impact of Terlipressin on Serum Sodium
Levels in Patients with HRS – the North American
Experience4
- Presenter: Shehzad Nawaz Merwat, MD
- Presentation Date: November 3,
2022; 10AM – 12PM ET
- Location: Exhibit Hall, Orange
County Convention Center, West Building
Abstract TH-PO037: Impact of HRS Reversal on the Need for
Renal Replacement Therapy – Analysis from 3 Phase III Terlipressin
Studies5
- Presenter: Muhammad Ahmad Mujtaba, MD
- Presentation Date: November 3, 2022; 10AM – 12PM ET
- Location: Exhibit Hall, Orange
County Convention Center, West Building
Find more information on the American Society of Nephrology
(ASN) Kidney Week 2022 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.6 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.7,8
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.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
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-2201045 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 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 American
Society of Nephrology Kidney Week 2022 (ASN) Scientific
Meeting. November 2022.
|
4 SN
Merwat. Impact of Terlipressin on Serum Sodium Levels in Patients
with HRS – the North American Experience. To be Presented
at the American Society of Nephrology Kidney Week 2022 (ASN)
Scientific Meeting. November 2022.
|
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 American Society of Nephrology Kidney
Week 2022 (ASN) Scientific Meeting. November 2022.
|
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. July 2020.
|
9 C
Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor,
R Gilroy, M OIyaee. Heptorenal syndrome in hospitalized patients
with chronic liver disease: results from the Nationwide Inpatient
Sample 2002-2012. J of Investig Med. 2016;
64:33-38.
|
10 United
States Census Bureau: Quick Facts. Available
at: https://www.census.gov/quickfacts/fact/table/US/PST045218.
Accessed October 13, 2022.
|
11 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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SOURCE Mallinckrodt plc