Ireland-based Mallinckrodt announced March 1 that the US FDA had approved its supplemental new drug application (sNDA) for the H.P. Acthar Gel single-dose pre-filled SelfJect injector.

SelfJect provides a subcutaneous dose of Acthar gel and is designed to give patients, including those with dexterity issues, control of their administration.

Extracted from the pituitary glands of pigs, the drug is a purified preparation of adrenocorticotropic hormone (ACTH) for patients with a range of chronic and acute inflammatory and autoimmune conditions.

Acthar gel is FDA-approved for the ophthalmic indication of treatment of severe acute and chronic allergic and inflammatory processes involving the eye (keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation). Other indications include arthritis, infantile spasms, and multiple sclerosis.

Mallinckrodt said Acthar gel has been prescribed by over 9,200 health care professionals and used by more than 43,500 patients.

SelfJect is expected to launch in the US in the second half of 2024, the company said. Acthar gel will continue to be available as an injection with a vial and syringe.

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