– Acthar Gel Single-Dose Pre-filled SelfJect
Injector is a self-controlled, pre-filled delivery
device1 for appropriate patients with a range of
chronic and acute inflammatory and autoimmune
conditions2 –
– This first-in-class delivery device reduces
the steps required for patients and caregivers to administer Acthar
Gel treatment1 and underscores Mallinckrodt's mission by advancing Acthar Gel
therapeutic modernization efforts to address patient needs
–
– Acthar Gel Single-Dose Pre-filled SelfJect
Injector is expected to launch in the U.S. in the second half of
2024 –
DUBLIN, March 1,
2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical
company, today announced that the U.S. Food and Drug Administration
(FDA) has approved Mallinckrodt's
supplemental New Drug Application (sNDA) for the Acthar®
Gel (repository corticotropin injection) Single-Dose Pre-filled
SelfJect™ Injector (herein referred to as "SelfJect"), a new
delivery device for Acthar Gel for appropriate patients with a
range of chronic and acute inflammatory and autoimmune
conditions.2 SelfJect is intended to provide the
appropriate subcutaneous dose of Acthar Gel, as prescribed by a
healthcare professional, and is designed to help give patients
control of their administration.1,3
Acthar Gel is a naturally sourced complex mixture of
adrenocorticotropic hormone analogs and other pituitary
peptides.2 Acthar Gel is approved by the U.S. FDA
for the treatment of several autoimmune disorders and medical
conditions known to cause inflammation.2
Please see Indications and Important Safety Information for
Acthar Gel below.
"We're excited to bring this innovation to U.S. patients with
chronic and acute inflammatory and autoimmune conditions. This
approval reflects Mallinckrodt's
longstanding commitment to clinical research and therapeutic
modernization efforts providing a new delivery device for patients,
caregivers, and medical professionals managing these challenging
conditions," said Peter
Richardson, MRCP (UK), Executive Vice President and Chief
Scientific Officer.
With this approval, Acthar Gel is the first in its class of
medications to offer a self-controlled, pre-filled delivery
device for appropriate patients with a range of chronic and
acute inflammatory and autoimmune
conditions.1,2 SelfJect may allow patients to
self-administer Acthar Gel with fewer steps, as prescribed by
a healthcare professional.1 The delivery device is
pre-filled with the prescribed dose of Acthar Gel in 40-unit or
80-unit versions,1 is designed to help patients with
dexterity issues,4 and has additional safety features
including a hidden needle to help protect patients against
needlestick injury.3
Acthar Gel has an established efficacy and safety profile, as
well as a long track record of clinical experience spanning more
than 70 years.2 Acthar Gel has been prescribed by
over 9,200 healthcare professionals and used by more than 43,500
patients.5
Mallinckrodt is committed to
providing therapy for appropriate patients with difficult-to-treat
conditions. Mallinckrodt offers a suite
of services for eligible Acthar Gel patients including support with
insurance coverage, commercial copay assistance, a patient
assistance program, injection training services, and customized
assistance by a nurse navigator. Mallinckrodt also offers a team of field-based
experts who provide education for healthcare professionals on the
reimbursement process as well as tools available for patients. For
more information about Mallinckrodt's
programs and patient support please visit ActharHCP.com.
SelfJect is expected to launch in the U.S. in the second half of
2024. Acthar Gel will continue to be available as an injection with
a vial and syringe.
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'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; 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.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
This release contains forward-looking statements, including with
regard to Acthar® Gel, the Acthar® Gel
(repository corticotropin injection) Single-Dose Pre-filled
SelfJect™ Injector, the potential of these products to improve
health and treatment outcomes, their potential impact on patients
and the availability of Acthar Gel Single-Dose Pre-filled SelfJect
Injector in the U.S. in the future. 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 effects of Mallinckrodt's recent emergence from bankruptcy;
satisfaction of, and compliance with, regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; changes in laws and regulations; changes in market
demand; issues with product quality, manufacturing or supply, or
patient safety issues or adverse side effects or adverse reactions
associated with Acthar Gel and Acthar Gel Single-Dose Pre-filled
SelfJect Injector; 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
908-577-4531
mediainquiries@grcomms.com
Investor Relations
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.
©2024 Mallinckrodt. US-2300898 02/24
References
1 Data on file – ref-05469. Mallinckrodt
Pharmaceuticals, Inc.
2 Acthar® Gel (repository corticotropin
injection) [prescribing information]. Mallinckrodt ARD LLC.
2024.
3 Data on file – ref-05573. Mallinckrodt
Pharmaceuticals, Inc.
4 Data on file – ref-05468. Mallinckrodt
Pharmaceuticals, Inc.
5 Data on file – ref-05336. Mallinckrodt
Pharmaceuticals, Inc.
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SOURCE Mallinckrodt plc