Single-Dose SelfJect Acthar Gel Now Available in US

Pharmaceutical company Mallinckrodt plc announced that, following the US Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for the ‘Acthar Gel Single-Dose Pre-filled SelfJect Injector’ (repository corticotropin injection), SelfJect is now available in the US.^1,2

The novel delivery device designed for Acthar Gel is designed for patients with a range of chronic and acute inflammatory and autoimmune conditions, the SelfJect device is for patients to maintain better control over their medications. The SelfJect injector allows for the correct subcutaneous administration of Acthar Gel, as prescribed by a healthcare professional.

"The launch of SelfJect is a significant advancement for patients who take Acthar Gel as it is designed to simplify the injection process, help ensure accurate dosing, and has enhanced safety features," Kostas Botsoglou, MD, Managing Partner of Rheumatology Center of Western New York, said in a statement. "SelfJect supports patients by helping to make treatment easier to administer than a multi-dose vial and syringe, particularly for patients with dexterity issues."²

The gel was approved by FDA officials and is a naturally derived complex combination of adrenocorticotropic hormone analogs and other pituitary peptides. The new approval of the SelfJect means that the gel will be the first medication in its class to offer a pre-filled, self-administered delivery device for patients who are eligible.¹

The SelfJect injector was designed with the goal of simplifying the process of administration. It is available in both 40-unit and 80-unit versions, with features included to assist individuals with dexterity problems and guard against needlestick-related injuries.

Acthar Gel is indicated for various conditions, some of which include acute exacerbations of multiple sclerosis, infantile spasms in children under 2, severe acute and chronic allergic and inflammatory eye conditions, systemic lupus erythematosus, and dermatomyositis (polymyositis). It also serves as an adjunctive therapy for those with psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis.

However, the announcement noted Acthar Gel’s contraindication for intravenous administration, among infants under 2 years with suspected congenital infections, with the use of live or live attenuated vaccines in immunosuppressed patients, and among those with conditions such as systemic fungal infections, osteoporosis, scleroderma, primary adrenocortical insufficiency, ocular herpes simplex, recent surgery, peptic ulcer history, congestive heart failure, uncontrolled hypertension, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin.

The Acthar Gel itself is known for its established efficacy and safety profile, given its prior 70 years of clinical use. Acthar Gel will be offered as an injection with a syringe and vial.

"I'm looking forward to being able to provide this option to appropriate patients in my practice to help them adhere to their treatment plans, which are intended to better their chances for improved outcomes," Botsoglou said in a statement.²

References

1. ^{Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector. Mallinckrodt plc. March 1, 2024. https://www.prnewswire.com/news-releases/mallinckrodt-announces-us-fda-approval-of-supplemental-new-drug-application-for-acthar-gel-repository-corticotropin-injection-single-dose-pre-filled-selfject-injector-302077212.html. Date accessed: August 6, 2024.}
2. ^{Mallinckrodt Announces Availability of Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector in the U.S. Mallinckrodt plc. August 6, 2024. https://www.mallinckrodt.com/about/news-and-media/news-detail/?id=31081. Date accessed: August 6, 2024.}