FDA Approves Single-Dose, Self-Controlled Delivery Device for Acthar Gel

The Food and Drug Administration (FDA) has approved a new single-dose prefilled SelfJect Injector of Acthar® Gel (repository corticotropin injection).

Acthar® Gel is indicated:

  • As monotherapy for the treatment of infantile spasms in infants and children under 2 years of age;
  • For the treatment of exacerbations of multiple sclerosis in adults; and
  • May be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state.

According to the Company, the new injector device is intended to allow adults to self-administer Acthar Gel with fewer steps and designed to help patients with dexterity issues. The device is for subcutaneous administration only and features a hidden needle to prevent needlestick injuries in users.

Acthar Gel single-dose prefilled SelfJect Injector is supplied as 40 USP Units/0.5mL and 80 USP Units/mL dosage strengths in a 4-count carton and is expected to be available in the second half of 2024. Acthar Gel is currently available in a 5mL multi-dose vial (80 USP Units/mL).

“We’re excited to bring this innovation to US patients with chronic and acute inflammatory and autoimmune conditions,” said Peter Richardson, MRCP (UK), Executive Vice President and Chief Scientific Officer. “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.” 

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