Mallinckrodt Launches Acthar® Gel Single-Dose Injector in the U.S.

Mallinckrodt plc, a prominent global specialty pharmaceutical company, has introduced the Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector, commonly referred to as "SelfJect." This innovation offers a new administration method for Acthar Gel, targeting patients with a variety of chronic and acute inflammatory and autoimmune conditions. The U.S. Food and Drug Administration (FDA) approved Mallinckrodt's supplemental New Drug Application (sNDA) for SelfJect in February 2024, indicating regulatory endorsement of this new delivery system.

Acthar Gel is a complex blend of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides. It has received FDA approval for the treatment of several autoimmune disorders and medical conditions characterized by inflammation. This medication stands out as the first and only adrenocorticotropic hormone product available in two forms of administration: a multi-dose vial and syringe, and the newly launched SelfJect.

SelfJect is a pre-filled, color-coded device designed for ease of use and safety. It comes in two dosages: 40 USP units/0.5 mL (green label) and 80 USP units/1.0 mL (purple label). Compared to the traditional multi-dose vial and syringe, SelfJect streamlines the preparation and administration process, reducing the number of materials and steps required. The device is latex-free and includes additional safety features, such as a hidden needle to protect against needlesticks. It is intended for subcutaneous administration in individuals aged 18 and older, delivering the prescribed dose accurately and safely.

Dr. Kostas Botsoglou, Managing Partner of Rheumatology Center of Western New York, praised the SelfJect as a significant advancement for patients using Acthar Gel. He highlighted that the device simplifies the injection process, ensures accurate dosing, and incorporates enhanced safety features. This is particularly beneficial for patients with dexterity issues, making treatment adherence easier and potentially improving health outcomes.

Acthar Gel boasts a well-established efficacy and safety profile, with over 70 years of clinical experience. The medication is accessible to more than 220 million individuals covered by commercial insurance and Medicare. Between 2013 and 2021, it was prescribed by over 9,200 healthcare professionals and used by more than 43,500 patients.

Lisa French, Executive Vice President & Chief Commercial Officer at Mallinckrodt, expressed excitement about the new SelfJect device, emphasizing its role in addressing patient needs and modernizing Acthar Gel's delivery system. She acknowledged the challenges of managing chronic and acute conditions and noted that the new device supports patients, caregivers, and medical professionals in this endeavor.

Mallinckrodt is dedicated to providing therapies for patients with difficult-to-treat conditions and offers a comprehensive suite of services for eligible Acthar Gel patients. These services include assistance with insurance coverage, commercial copay support, a patient assistance program, injection training, and personalized help from a nurse navigator. Additionally, field-based experts are available to educate healthcare professionals about the reimbursement process and available patient tools.

For patients who prefer or require the traditional administration method, Acthar Gel continues to be available in the multi-dose vial. This method is suitable for patients needing doses other than 40 or 80 units. It's important to note that SelfJect is not intended for treating infantile spasms. The process for initiating new patients on Acthar Gel with SelfJect remains unchanged from the traditional multi-dose vial method. Interested individuals can learn more by contacting their local representative or visiting the official website.

Acthar Gel is indicated for various conditions, including nephrotic syndrome, infantile spasms, acute exacerbations of multiple sclerosis, severe eye inflammation, sarcoidosis, systemic lupus erythematosus, systemic dermatomyositis, and as adjunctive therapy for certain types of arthritis and ankylosing spondylitis.

Mallinckrodt remains a global leader in developing, manufacturing, marketing, and distributing specialty pharmaceutical products, with a focus on autoimmune and rare diseases across several medical specialties.