FDA Approves Single-Dose SelfJect Injector Delivery Device for Inflammatory and Autoimmune Conditions

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The delivery device is prefilled with the prescribed dose of Acthar Gel in 40- or 80-unit versions, and may help administration of the appropriate subcutaneous dose of Acthar Gel.

Peter Richardson, MRCP

Peter Richardson, MRCP

(Credit: LinkedIn)

According to a recent announcement, the FDA has approved a new single-dose, pre-filled delivery device, named SeflJect, to be used for Acthar Gel (repository corticotropin injection; Mallinckrodt), a treatment indicated for a various number of chronic and acute inflammatory and autoimmune conditions, including multiple sclerosis (MS). SelfJect is intended to provide an appropriate subcutaneous dose of the therapy and may help improve patients' control of administration.1

SelfJect, which may allow for fewer steps during the self-administration of Arthar Gel, is expected to launch in the US in the second half of 2024. Acthar Gel, which has been prescribed by more than 9200 health care professionals, is indicated for a number of different conditions, including for acute exacerbations of MS, infantile spasms, symptomatic sarcoidosis, and acute and chronic allergic and inflammatory processes involving the eye and its adnexa.

"We're excited to bring this innovation to US patients with chronic and acute inflammatory and autoimmune conditions," Peter Richardson, MRCP, executive vice president and chief scientific officer at Mallinckrodt, said in a statement.1 "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."

READ MORE: FDA Issues Complete Response Letter for Long-Acting Form of Glatiramer Acetate for Relapsing Multiple Sclerosis

Acthar Gel is also indicated as a treatment during an exacerbation or as a maintenance therapy in selected cases of systemic lupus erythematosus and dermatomyositis. In addition, it can be used as an adjuvant for short-term administration in psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis, and ankylosing spondylitis. Its contraindications include infants under 2 years of age with suspected congenital infections, concomitant use of live attenuated vaccines in patients on immunosuppressive doses of Acthar, and in patients with scleroderma, osteoporosis, systemic fungal infections, and ocular herpes simplex, among others.

The newly approved SelfJect comes with the prescribed dose of Acthar Gel in 40-unit or 80-unit versions, and may help patients with dexterity issues. Additionally, safety features such as its hidden needle are intended to help protect patients against needlestick injury. As the community waits for SelfJect to be officially launched, Acthar Gel will continue to be available as an injection with a vial and syringe.

Acthar comes with a number of potential adverse events (AEs), mainly driven from its steroidogenic effects. It may cause elevated blood pressure, salt and water retention, and hypokalemia, as well as gastrointestinal bleeding and gastric ulcer. Caution may be warned for those with comorbid disease, including patients with diabetes and myasthenia gravis. Acthar is immunogenic and prolonged administration of the treatment may increase the risk of hypersensitivity reactions.

REFERENCE
1. Mallinckrodt announces US FDA approval of supplemental new drug application for Acthar Gel (repository corticotropin injection) single-dose pre-filled SelfJect injector. News release. Mallinckrodt. March 1, 2024. Accessed March 11, 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
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