FDA approves Acthar Gel SelfJect injector in autoimmune, inflammatory conditions
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Key takeaways:
- The Acthar Gel SelfJect injector is indicated for acute exacerbations of multiple sclerosis and certain cases of lupus, and as an adjunct in several other rheumatic diseases.
- The drug will still be available as an injection with a vial and syringe.
The FDA has approved a supplemental new drug application for an Acthar Gel injector for the treatment of several chronic and acute inflammatory and autoimmune conditions, according to the manufacturer.
Expected to launch in the United States in the second half of 2024, the Acthar Gel (corticotropin, Mallinckrodt Pharmaceuticals) single-dose pre-filled SelfJect injector is indicated in acute exacerbations of multiple sclerosis; selected cases of systemic lupus erythematosus and polymyositis; as an adjunctive therapy for psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis; as well as other conditions, according to a press release from Mallinckrodt.
“We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions,” Peter Richardson, MRCP, executive vice president and chief scientific officer at Mallinckrodt, said in the release. “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.”
The SelfJect injector is pre-filled with a prescribed dose for subcutaneous injection, available in 40 units or 80 units, and features a hidden needle to protect against needlestick injury. Mallinckrodt said it will continue to make corticotropin available as a vial-and-syringe injection.
Corticotropin is a “naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides,” according to the release.
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