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Mallinckrodt
Announces Publication of Two Journal Manuscripts with Clinical and Economic Evidence for
Acthar
® Gel (Repository Corticotropin Injection)
2023-10-10
·
BioSpace
上市批准
临床结果
Clinical findings from historical manuscript published in Clinical Drug Investigation reinforce the efficacy, safety profile, and use of
Acthar Gel
in appropriate patients across 12 autoimmune and inflammatory indications1 Economic findings from manuscript published in ClinicoEconomics and Outcomes Research support
Acthar Gel
's clinical and economic benefits for patients across nine autoimmune and inflammatory indications2 DUBLIN, Oct. 10, 2023 /PRNewswire/ --
Mallinckrodt plc
(OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the publication of two journal manuscripts reinforcing the clinical and economic evidence supporting the efficacy, safety profile, continued use, and cost-effectiveness of Acthar Gel for appropriate patients across a range of FDA-approved autoimmune and inflammatory disease indications.1,2
Mallinckrodt
's clinical manuscript titled "Acthar Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: A Historical Perspective and Characterization of Clinical Evidence" was published on October 4, 2023 in the journal, Clinical Drug Investigation.
Mallinckrodt
's health economics manuscript titled "Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence" was published on June 24, 2023 in ClinicoEconomics and Outcomes Research. Acthar is a naturally sourced complex mixture of
adrenocorticotropic hormone analogs
and other pituitary peptides.
Acthar
Gel is approved by the
U.S. Food and Drug Administration (FDA)
for the treatment of several
autoimmune disorders
and medical conditions known to cause
inflammation.3
Please see indications and Important Safety Information below. Authored by Jeffrey Kaplan, M.D., Kansas City
Multiple Sclerosis
&
Headache
Center, and colleagues, "
Acthar
Gel Treatment for Patients with
Autoimmune and Inflammatory Diseases
: A Historical Perspective and Characterization of Clinical Evidence," sought to review the history of
Acthar
and the findings of existing literature on preclinical and clinical studies that have investigated the mechanism of action, safety profile, efficacy, and real-world effectiveness of
Acthar
. The indications addressed in the study include the treatment of
inflammatory diseases
such as
rheumatoid arthritis (RA)
,
systemic lupus erythematosus (SLE)
,
dermatomyositis
and
polymyositis (DM/PM)
,
multiple sclerosis (MS)
relapse,
inflammatory ocular diseases
,
sarcoidosis
, and
nephrotic syndrome (NS).1
As a result of this analysis spanning more than 20 preclinical mechanistic studies and 15 clinical studies with a combined enrollment of approximately 900 patients, and the publication of over 500 manuscripts and abstracts to date, the findings reinforce the safety profile, efficacy, and usage of
Acthar
in appropriate patients with inflammatory diseases for whom standard treatments may have become ineffective or associated with intolerable side effects.1 "
Acthar
® Gel has an established efficacy and safety pro by robust clinical research and experience," said Dr. Kaplan. "For patients and providers managing the challenges associated with chronic inflammatory and autoimmune conditions, the findings of this study further elucidate Acthar's proposed mechanism of action and reinforce the extensive history of clinical evidence that has shown its potential to improve health and treatment outcomes across a range of FDA-approved indications."1 This publication is accompanied by an Audiocast. All six authors across specialties representing key Acthar Gel indications researched in this study discuss a brief overview of the manuscript, including the history of Acthar, its mechanism of action (MOA), and clinical characteristics, in addition to introductions on each author and reflections on their own personal experiences with Acthar in clinical practice. Authored by George J. Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences at
Mallinckrodt
, and colleagues, "Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence" reviewed key studies of clinical efficacy and healthcare resource utilization and cost from 1956 to 2022 to summarize the key clinical and economic findings among nine FDA-approved
Acthar Gel
indications:
infantile spasms (IS)
,
MS
relapse,
RA
,
SLE
,
DM
/PM,
ocular inflammatory diseases
(
primary uveitis
and severe
keratitis
), symptomatic
sarcoidosis
, and
proteinuria
in NS.2 This analysis found that among all nine medical conditions studied,
Acthar
has shown effectiveness in reducing symptoms, improving functioning and well-being, reducing disease relapse, and/or increasing disease remission.2 Economic data from this analysis suggests that
Acthar
is a cost-effective, value-based treatment option for
MS
relapse,
RA
, and
SLE
. Other economic benefits have been demonstrated for IS,
MS
relapses,
RA
,
SLE
, and
DM
/PM, including reduced hospitalizations, length of stay, inpatient and outpatient services, and emergency department visits.2 "The findings of this health-economics analysis deepen our understanding of
Acthar
's ability to serve as a cost-effective, value-based treatment option across multiple FDA-approved indications studied – including how appropriate use of
Acthar
may be associated with reduction of healthcare utilization costs such as total hospitalizations, patient length of stay, and concurrent treatment burden, such as the use of corticosteroids,"2 said Wan. Data collected in a retrospective analysis may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical outcomes may not be solely attributable to Acthar. These studies were funded by
Mallinckrodt Pharmaceuticals
. ABOUT
DERMATOMYOSITIS
/
POLYMYOSITIS (DM/PM)
DM
/PM are rare
inflammatory diseases
that cause
progressive muscle weakness,4
usually in the muscles closest to the trunk of the body.5 For instance,
muscle weakness
associated with PM involves those in the hips, thighs, shoulders, upper arms, and neck.6
DM
also causes
skin rashes.7
People of all ages can be affected, though it usually occurs between the ages of 40-60 and is more common in women.7,8 ABOUT
INFANTILE SPASMS (IS)
IS is a rare
seizure disorder
that affects approximately 2,500 children in the U.S. every year.9 It most commonly occurs between three and seven months of age.9 Sometimes called
West syndrome
, IS demands early identification, diagnosis, and treatment to help limit lasting effects.9 Children with IS generally have one or more of the following symptoms: a certain type of
seizure
(called "
spasms
"), a disorganized and chaotic brain-wave pattern called
hypsarrhythmia
as recorded on an EEG (electroencephalogram).10 ABOUT
MULTIPLE SCLEROSIS
(
MS
)
MS
is a
chronic neurologic disorder
that affects the central nervous system (i.e., the brain and spinal cord).11 Symptoms can include
fatigue
, mobility issues, numbness or
tingling
, vision problems,
muscle spasticity
,
tremors
, and cognitive changes.12,13 More than eight in 10 people with
MS
will experience a relapse, or flare-up, that brings new or worsening symptoms.12 ABOUT
PROTEINURIA
IN
NEPHROTIC SYNDROME (NS)
NS is a collection of symptoms that occur when the blood vessels in the kidney begin to leak excess protein in the urine, a condition called
proteinuria.14
A variety of diseases and underlying disorders damage the kidneys and cause
proteinuria
in people with NS.14 These etiologies can include
glomerular diseases
such as:
idiopathic membranous nephropathy
,
focal segmental glomerulosclerosis
,
minimal change disease
,
membranoproliferative glomerulonephritis
,
lupus nephritis
, and IgA
nephropathy.15,16,17,18
In these and other related disorders, the glomeruli, or small blood vessels that work as the kidney's filtering system, are damaged.14
Proteinuria
is one of the most important adverse prognostic factors for progression to
end stage renal failure
in patients with
glomerular disease
. One of the goals of treating NS includes reducing or eliminating
proteinuria.19
ABOUT
RHEUMATOID ARTHRITIS (RA)
RA
is an
autoimmune disease.20
It is a chronic condition that causes
pain
, stiffness, and
swelling
of the joints – all symptoms caused by
inflammation.20
An estimated 1.5 million U.S. adults are living with
RA.20
ABOUT
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
SLE
is an
autoimmune disease
in which the immune system produces antibodies to cells within the body leading to possible
inflammation
and tissue damage.21 It is the most common form of lupus,21 a condition that impacts an estimated 1.5 million Americans.22 Far more of those diagnosed with lupus are women, often between the ages of 15-44.21 Lupus is characterized by periods of illness "flares" and remissions and the disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels.21 Symptoms may include
fatigue
,
pain
or
swelling
in joints,
skin rashes
, and
fevers.21
ABOUT SYMPTOMATIC
SARCOIDOSIS
Sarcoidosis
is a challenging and rare multisystem disease.23 In some cases, the symptoms may come and go throughout a lifetime.23 This is referred to as symptomatic
sarcoidosis.23
In people with
sarcoidosis
the immune system overreacts, forming clumps of cells called granulomas that result in
inflammation
to the body's tissues.24 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, and skin.25 Nearly 90 percent of people with
sarcoidosis
will suffer lung problems.25 Concomitant involvement of organs outside of the lungs is common, occurring in more than half of all
sarcoidosis
cases, according to one study.26 ABOUT
UVEITIS
Uveitis
is a mix of
acute or chronic inflammatory eye disorders
that affects the uveal tract (a layer of tissue just behind the outer layer of the eye) and adjacent structures, including the sclera, cornea, vitreous humor, retina, and optic nerve head.27,28,29,30 Symptoms vary based on the site of
inflammation
, but can include
decreased vision
,
eye pain
,
tearing
,
redness
, light sensitivity, and floaters.27,28
Uveitis
has numerous etiologies, associated conditions, and underlying immune responses that complicate its diagnosis and treatment.28,31
Uveitis
accounts for up to 10% of cases of
legal blindness
in the United States. In the United States, the annual incidence (occurrence of new cases) of
uveitis
ranges between 17.4 and 52.4 per 100,000 person-years.32,33,34 It most affects individuals of working age.28 ABOUT SEVERE
KERATITIS
Keratitis
is a
painful inflammation
of the cornea which can result in partial or total loss of vision if left untreated and is a significant cause of ocular morbidity around the world.35 It can result from infectious agents (e.g., microbes including bacteria, fungi, amebae, and viruses) or from non-infectious causes (e.g., eye trauma, chemical exposure, and ultraviolet exposure).36 Conditions that affect the integrity of the ocular surface epithelium (
exposure keratitis
,
neurotrophic keratitis
,
keratomalacia
,
recurrent corneal erosions
) may also lead to development of sterile corneal ulcers.37 Non-
infectious corneal ulcers
may be associated with various collagen vascular or other autoimmune diseases, sometimes as the presenting sign of the disease.37 INDICATIONS Acthar Gel is indicated for: Inducing a diuresis or a remission of
proteinuria
in
nephrotic syndrome
without
uremia
of the idiopathic type or that due to lupus erythematosus Monotherapy for the treatment of
infantile spasms
in infants and children under 2 years of age Treatment of acute exacerbations of
multiple sclerosis
in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of
multiple sclerosis
. However, there is no evidence that it affects the ultimate outcome or natural history of the disease Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
keratitis
,
iritis
,
iridocyclitis
,
diffuse posterior uveitis
and
choroiditis
,
optic neuritis
,
chorioretinitis
,
anterior segment inflammation
Symptomatic
sarcoidosis
Treatment during an exacerbation or as maintenance therapy in selected cases of
systemic lupus erythematosus
Treatment during an exacerbation or as maintenance therapy in selected cases of
dermatomyositis
(
polymyositis
) Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
psoriatic arthritis
;
rheumatoid arthritis
, including
juvenile rheumatoid arthritis
(selected cases may require low-dose maintenance therapy);
ankylosing spondylitis
IMPORTANT SAFETY INFORMATION Contraindications
Acthar
is contraindicated: For intravenous administration In infants under 2 years of age who have suspected
congenital infections
With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of
Acthar
In patients with
scleroderma
,
osteoporosis
,
systemic fungal infections
,
ocular herpes simplex
, recent surgery, history of the presence of a
peptic ulcer
,
congestive heart failure
, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin Warnings and Precautions The adverse effects of Acthar are related primarily to its steroidogenic effects Acthar may increase susceptibility to new
infection
or reactivation of
latent infections
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for
adrenal insufficiency
after withdrawal of the medication.
Adrenal insufficiency
may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g.,
trauma
or surgery) by the use of corticosteroids. Monitor patients for effects of
HPA axis
suppression after stopping treatment
Cushing's syndrome
may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms Acthar can cause elevation of blood pressure, salt and water retention, and
hypokalemia
. Monitor blood pressure and sodium and potassium levels Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy Acthar can cause
gastrointestinal (GI) bleeding
and
gastric ulcer
. There is also an increased risk for perforation in patients with certain
GI disorders
. Monitor for signs of perforation and
bleeding
Acthar may be associated with central nervous system effects ranging from euphoria,
insomnia
,
irritability
, mood swings, personality changes, and severe
depression
to
psychosis
. Existing conditions may be aggravated Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing
Acthar
in patients with
diabetes
and
myasthenia gravis
Prolonged use of
Acthar
may produce
cataracts
,
glaucoma
, and
secondary ocular infections
. Monitor for signs and symptoms
Acthar
is immunogenic and prolonged administration of
Acthar
may increase the risk of
hypersensitivity reactions
. Cases of
anaphylaxis
have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous
ACTH
and Acthar activity There may be an enhanced effect in patients with
hypothyroidism
and in those with
cirrhosis of the liver
Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy Adverse Reactions Commonly reported postmarketing adverse reactions for Acthar include
injection site reaction
,
asthenic conditions
(including
fatigue
, malaise,
asthenia
, and
lethargy
),
fluid retention
(including
peripheral swelling
),
insomnia
,
headache
, and blood glucose increased The most common adverse reactions for the treatment of
infantile spasms (IS)
are increased risk of
infections
,
convulsions
,
hypertension
,
irritability
, and
pyrexia
. Some patients with IS progress to other forms of
seizures
; IS sometimes masks theses
seizures
, which may become visible once the clinical spasms from IS resolve Pregnancy Acthar may cause fetal harm when administered to a pregnant woman Please see full Prescribing Information for additional Important Safety Information. 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 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
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
Acthar
® Gel, its potential to improve health and treatment outcomes, its ability to reduce healthcare utilization costs, 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 or adverse side effects or adverse reactions associated with Acthar; pricing pressure on
Mallinckrodt
's products due to legal changes or changes in insurers' reimbursement practices from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; 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 mediainquires@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-2300691 9/23 References 1 Data on File. Ref-06841. Mallinckrodt Pharmaceuticals. 2 Wan GJ., Niewoehner J., Hayes K. Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence. ClinicoEconomics and Outcomes Research. 2023; 15:499-512. 3 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC. 4 Types of
Myositis
. The Myositis Association. Available at: . Accessed August 2023. 5 Medline Plus.
Myositis
. Available at: . Accessed August 2023. 6 Mayo Clinic.
Polymyositis
. Available at: . Accessed August 2023. 7 Rheumatology Center. About
Dermatomyositis
and
Polymyositis
. Available at: . Accessed August 2023. 8 Bernatsky S, et al. Estimating the prevalence of
polymyositis
and
dermatomyositis
from administrative data: age, sex and regional differences. Ann Rheum Dis. 2008;68:1192-1196. 9 Wheless J, Gibson P, Rosbeck K, et al.
Infantile spasms (West syndrome)
: update and resources for pediatricians and providers to share with parents. BMC Pediatrics. 2012;12(1):108. doi:10.1186/1471-2431-12-108. 10 Go CY, Mackay MT, Weiss SK, et al. Evidence-based guideline update: medical treatment of
infantile spasms
. Neurology. 2012; 78:1974-1980. 11 Multiple Sclerosis Foundation. Get Educated-Common Questions-
Multiple Sclerosis
. Available at: . Accessed August 2023. 12 National Multiple Sclerosis Society.
Relapsing-remitting MS (RRMS)
. Available at: . Accessed August 2023. 13 National Multiple Sclerosis Society.
MS
Symptoms & Signs of
MS
. Available at: . Accessed September 2023. 14 National Institute of Health. National Institute of
Diabetes
and
Digestive Kidney Diseases
.
Nephrotic Syndrome
in Adults. 2020. Available at: . Accessed September 2023. 15 NephCure Kidney International. Nephrotic Syndrome. Available at . Accessed September 2023 16 NephCure Kidney International. Focal Segmentation
Glomerulosclerosis
. Available at . Accessed September 2023. 17 NIDDK. IgA Nephropathy. Available at: . Accessed September 2023. 18 Satpathy HK. IgA Nephropathy. In: Ferri FF, ed. Ferri's Clinical Advisor 2013. 1st ed. St Louis: Mosby; 2012; 570-571. 19 Troyanov et al. J Am Soc Nephrol. 2005;16(4):1061–1068. 20 What is
Rheumatoid Arthritis
? Arthritis Foundation. Available at: . Accessed August 2023. 21 Lupus Detailed Fact Sheet. 2018. The Centers for Disease Control and Prevention. Available at: . Accessed September 2023. 22 Lupus Foundation of America. National Resource Center on Lupus. Lupus Fact and Statistics. 2018. Available at: . Accessed September 2023. 23
Sarcoidosis
. American College of Chest Physicians. Available at: . Accessed September 2023. 24
Sarcoidosis
Overview. 2019. Cleveland Clinic. Available at: . Accessed September 2023. 25 Judson MA, Boan AD, Lackland DT. The Clinical Course of
Sarcoidosis
: Presentation, Diagnosis, and Treatment in a Large White and Black Cohort in the United States.
Sarcoidosis
Vasc Diffuse Lung Dis. 2012. 29(2);119-127. 26 Chopra I, et al. Repository Corticotropin Injection in Patients with Advanced Symptomatic Sarcoidosis: Retrospective Analysis of Medical Records. Ther Adv Res Dis. 2019(13);1-11. DOI: 10.1177/1753466619888127. 27 Barisani-Asenbauer T, Maca SM, Mejdoubi L, Emminger W, Machold K, Auer H.
Uveitis
—a rare disease often associated with systemic diseases and
infections
—a systematic review of 2619 patients. Orphanet J Rare Dis. 2012;7:57. 28 Mustafa M, Muthusamy P, Hussain SS, Shimmi SC, Sein MM.
Uveitis
: pathogenesis, clinical presentations and treatment. IOSR J Pharm. 2014;4:42-47. 29 Guly CM, Forrester JV. Investigation and management of
uveitis
. BMJ. 2010;341:c4976. 30 Chan CC, Li Q. Immunopathology of
uveitis
. Br J Ophthalmol. 1998;82:91-99. 31 Lee RWJ, Dick AD. Current concepts and future directions in the pathogenesis and treatment of
non-infectious intraocular inflammation
. Eye. 2012;26(1):17-28. doi:10.1038/eye.2011.255. 32 Acharya, NR, Tham VM, Esterberg E, et al. Incidence and prevalence of
uveitis
: results from the Pacific
Ocular Inflammation
Study. JAMA Ophthalmol. 2013;131:1405-1412. 33 Gritz DC, Wong IG. Incidence and prevalence of
uveitis
in Northern California; the Northern California Epidemiology of
Uveitis
Study. Ophthalmology. 2004;111:491-500; discussion 500. 34 Suhler EB, Lloyd MJ, Choi D, Rosenbaum JT, Austin DF Incidence and prevalence of
uveitis
in Veterans Affairs Medical Centers of the Pacific Northwest. Am. J. Ophthalmol. 2008;146:890.e8–896.e8 35 Sharma S. Keratitis. Bioscience Reports. 2001;21:419-444. 36 Collier SA, Gronostaj MP, MacGurn, AK, Cope JR, Awsumb KL, Yoder JS, et al. Estimated burden of
keratitis
--United States, 2010. MMWR Morb Mortal Wkly Rep. 2014;63(45):1027–1030. 37 Donzis PB, Mondino BJ. Management of
noninfectious corneal ulcers
. Surv Ophthalmol. 1987;32:94–110. View original content to download multimedia: SOURCE Mallinckrodt plc Company Codes: OTC-BB:MNKTQ, OTC-PINK:MNKTQ
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