Purified Cortrophin Gel (repository corticotropin injection USP) is now available for the treatment of certain chronic autoimmune disorders, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, and excess urinary protein due to 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 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 due to lupus erythematosus.
  • Acute exacerbations of multiple sclerosis.

Cortrophin Gel may be administered subcutaneously or intramuscularly.

“With today’s full-scale commercial launch of Cortrophin Gel, an established treatment, health care professionals now have another ACTH [adrenocorticotropic hormone] therapy option, with US-based development, supply chain and manufacturing,” said Nikhil Lalwani, President and Chief Executive Officer of ANI.

Purified Cortrophin Gel is supplied in 5mL multiple-dose vials containing 80 Units/mL. The product is available through a network of specialty pharmacies and distributors. Information on patient enrollment can be found here.

References

  1. ANI Pharmaceuticals announces commercial availability of Purified CortrophinGel (repository corticotropin injection USP) for multiple chronic autoimmune disorders. News release. ANI Pharmaceuticals, Inc. Accessed January 24, 2022. https://www.businesswire.com/news/home/20220124005040/en/ANI-Pharmaceuticals-Announces-Commercial-Availability-of-Purified-Cortrophin%E2%84%A2-Gel-Repository-Corticotropin-Injection-USP-for-Multiple-Chronic-Autoimmune-Disorders
  2. Purified Cortrophin Gel. Package insert. ANI Pharmaceuticals, Inc.; 2021. Accessed January 24, 2022. https://www.cortrophin.com/pdfs/purified-cortrophin-gel-prescribing-information.pdf