Mallinckrodt Launches Acthar® Gel SelfJect™ Injector In The U.S.

Mallinckrodt plc, a leading global specialty pharmaceutical company, has announced the launch of the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector (referred to as "SelfJect"). This new administration option is designed for patients with various chronic and acute inflammatory and autoimmune conditions. The U.S. Food and Drug Administration (FDA) granted approval for Mallinckrodt's supplemental New Drug Application (sNDA) for SelfJect in February 2024.

Acthar Gel is the only medication in its class of adrenocorticotropic hormone products that offers two administration options: a multi-dose vial and the new SelfJect device. The SelfJect is color-coded for easy identification, available in two strengths—40 USP units/0.5 mL (green label) and 80 USP units/1.0 mL (purple label). This innovative device simplifies the administration process, requiring fewer materials and steps than the multi-dose vial. Additionally, the latex-free SelfJect includes safety features such as a hidden needle to minimize the risk of needlesticks. Designed for subcutaneous use, it is intended for adults 18 and older and ensures the delivery of the prescribed dose of Acthar Gel from a healthcare professional.

Kostas Botsoglou, MD, Managing Partner of Rheumatology Center of Western New York, said, "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. SelfJect supports patients by helping to make treatment easier to administer than a multi-dose vial and syringe, particularly for patients with dexterity issues. 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.”

"We're excited to deliver an option that not only helps to address the needs of the patient communities we serve, but also underscores our commitment to the modernization of Acthar Gel. We know that managing chronic and acute inflammatory and autoimmune conditions can be difficult, and we're proud to offer this new delivery device, designed to better support patients, caregivers, and medical professionals in managing appropriate conditions," added Lisa French, Executive Vice President & Chief Commercial Officer.