FDA Approves Cortrophin Gel in Prefilled Syringe Presentation

The Food and Drug Administration (FDA) has approved Purified Cortrophin^® Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

Cortrophin Gel is a purified adrenocorticotropic hormone. 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 that due to lupus erythematosus.
• Acute exacerbations of multiple sclerosis.

The new single-dose prefilled syringes will be available in 40 USP units/0.5mL and 80 USP units/mL dosage strengths. Cortrophin Gel will also continue to be supplied in 5mL (400 USP units/5mL) and 1mL (80 USP units/mL) multi-dose vials.

“Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment,” said Nikhil Lalwani, President and Chief Executive Officer of ANI. “We look forward to making the Cortrophin Gel prefilled syringe available in the second quarter of 2025 as we continue to advance our rare disease portfolio.”

Cortrophin Gel is available through a network of specialty pharmacies and distributors. Information on patient enrollment can be found here.

This article originally appeared on MPR