– TERLIVAZ® (terlipressin) is
the only FDA approved treatment for adults with HRS with rapid
reduction in kidney function1 –
DUBLIN, May 5, 2023
/PRNewswire/ -- Mallinckrodt
plc (NYSE American: MNK), a global specialty pharmaceutical
company, is pleased to announce it has received an award from the
National Organization for Rare Disorders (NORD), recognizing it as
an "Industry Innovator" for the creation of a treatment "to improve
the lives of rare disease patients." Mallinckrodt is being recognized for the U.S. Food
and Drug Administration (FDA) approval of
TERLIVAZ® (terlipressin) for injection for the
treatment of adults with HRS with rapid reduction in kidney
function.1
TERLIVAZ, the first and only FDA-approved product indicated for
the treatment of adults with Hepatorenal Syndrome (HRS) involving
rapid reduction in kidney function,1 an acute and
life-threatening condition requiring hospitalization,2
was approved for use on September 14,
2022.
Please see Limitation of Use and Important Safety
Information, including Boxed Warning, below.
Peter Richardson, MRCP (UK),
Executive Vice President & Chief Scientific Officer at
Mallinckrodt, said, "We are honored
to receive this award from NORD. TERLIVAZ® is an
important treatment option for patients faced with this
life-threatening condition and for their U.S. physicians who
historically have had limited treatment options.3 We are
grateful to the patients who participated in our clinical trials,
their caregivers and healthcare providers, and the team at
Mallinckrodt who worked tirelessly to
advance TERLIVAZ."
The presentation of awards took place the evening of
May 4th, during NORD's
2023 Rare Impact Awards in Washington,
D.C. Find more information on the Rare Impact Awards
website, and see the full list of Industry Innovators in the recent
press release.
About the National Organization for Rare Disorders
(NORD)
With a 40-year history of advancing care, treatments
and policy, the National Organization for Rare Disorders (NORD) is
the leading and longest-standing patient advocacy group for the
more than 25 million Americans living with a rare disease. NORD, a
501(c)(3) nonprofit, is dedicated to individuals with rare diseases
and the organizations that serve them. NORD, along with its more
than 330 patient organization members, is committed to improving
the health and well-being of people with rare diseases by driving
advances in care, research and policy. For more information, please
visit https://rarediseases.org/.
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.4, 5 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.6
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 contains forward-looking statements,
including with regard to TERLIVAZ 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: 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@grcomms.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.
©2023 Mallinckrodt. US-2300255 5/23
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 April 27, 2023.
3 Belcher, et al. Terlipressin and the Treatment of
Hepatorenal Syndrome: How the CONFIRM Trial Moves the Story
Forward. Am J Kidney Dis. 2022;79(5):737-745.
doi:10.1053/j.ajkd.2021.08.016.
4 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.
5 United States Census Bureau: Quick Facts. Available
at: https://www.census.gov/quickfacts/fact/table/US/PST045218.
Accessed April 27, 2023.
6 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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