Le Lézard
Classified in: Health
Subject: FDA

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJecttm Injector


? Acthar Gel Single-Dose Pre-filled SelfJect Injector is a self-controlled, pre-filled delivery devicefor 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 SelfJecttm 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.

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.

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.

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:

IMPORTANT SAFETY INFORMATION

Contraindications

Acthar is contraindicated:

Warnings and Precautions

Adverse Reactions

Pregnancy

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 SelfJecttm 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
[email protected]

Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
[email protected]

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.

 

SOURCE Mallinckrodt plc


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