The Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of certain autoimmune disorders, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.
Cortrophin Gel is a purified adrenocorticotropic hormone. In January 2016, ANI Pharmaceuticals acquired the New Drug Application for Cortrophin Gel from Merck and submitted the supplemental application to the FDA in March 2020.
Specifically, the product is indicated for:
- Adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, and acute gouty arthritis.
- During an exacerbation or as maintenance therapy in selected cases of of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
- Severe erythema multiforme (Stevens-Johnson syndrome).
- Severe psoriasis.
- Atopic dermatitis.
- Serum sickness.
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.
- Symptomatic sarcoidosis.
- Inducing diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
- Acute exacerbations of multiple sclerosis.
“Patients who are refractory or intolerant to corticosteroids have an especially urgent need for effective alternatives and are at risk of ongoing organ damage with long-term disease,” said Mary Pao Seideman, MD, PhD, Chief Medical Officer of ANI Pharmaceuticals. “For over 30 years, there has only been one available treatment in the ACTH category. With the FDA approval of Cortrophin Gel, patients will now have a significant new treatment option.”
Purified Cortrophin Gel is supplied in 5mL multiple-dose vials containing 80 Units/mL. It may be administered subcutaneously or intramuscularly.
The product is expected to be available in the first quarter of 2022.
- ANI Pharmaceuticals announces FDA approval of Purified Cortrophin™ Gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome. News release. November 1, 2021. https://www.businesswire.com/news/home/20211101005292/en/ANI-Pharmaceuticals-Announces-FDA-Approval-of-Purified-Cortrophin%E2%84%A2-Gel-for-Multiple-Indications-Including-Multiple-Sclerosis-Rheumatoid-Arthritis-and-Nephrotic-Syndrome.
- Purified Cortrophin™ Gel. Package insert. ANI Pharmaceuticals. 2021. Accessed November 1, 2021. https://www.anipharmaceuticals.com/docs/purified-cortrophin-gel-prescribing-information.pdf.