FDA Approves Reintroduced Cortrophin Gel for MS Exacerbations

The injectable ACTH gel medication Cortrophin Gel (repository corticotropin injection), first introduced in the U.S. in the 1950s, will now be relaunched as a treatment for acute flare-ups in multiple sclerosis (MS) and other autoimmune conditions, following its approval by the U.S. Food and Drug Administration (FDA).

In addition to MS, the FDA has now approved Cortrophin Gel for indications that include acute exacerbations from rheumatoid arthritis, and excess protein in the urine due to nephrotic syndrome.

ANI Pharmaceuticals is planning a full-scale commercial launch of Cortrophin Gel in early first-quarter 2022, the company announced in a press release.

The therapy, which can be injected under the skin (subcutaneously) or into the muscle (intramuscular), had been previously approved by the FDA in 1954 for multiple autoimmune diseases, but it fell out of use in the 1980s. ANI has spent the last five years working to bring the gel back to the market, the company said.

“FDA’s approval of Cortrophin Gel enables us to bring a much-needed treatment choice to patients with acute exacerbations of multiple sclerosis,” said Nikhil Lalwani, president and CEO of ANI Pharmaceuticals.

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Cortrophin Gel consists of an adrenocorticotropic hormone (ACTH). It works by enhancing the production of corticosteroids by certain glands in the body, which help to reduce inflammation and more rapidly resolve MS relapses.

In recent years, the only repository corticotropin injection available in the U.S. was Mallinckrodt Pharmaceuticals’ Acthar Gel.

ANI had previously announced plans to sell its Cortrophin Gel “at a substantial discount,” potentially enabling more patients to access this treatment.

“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,” said Mary Pao Seideman, MD, PhD, chief medical officer of ANI Pharmaceuticals.

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ANI had first acquired the new drug application from Merck (known as MSD outside North America) in 2016. Since then, the company had invested a significant amount of time and resources in establishing and updating its manufacturing procedures and creating a sustainable U.S.-based supply chain.

The newly approved product is expected to be available in the U.S. market early next year.

“We are pleased to offer Cortrophin Gel, an established treatment, to provide another option to patients and prescribers,” said Lalwani. “This approval reflects ANI’s commitment to the patients and physicians we serve, combined with U.S.-based development and manufacturing.”

As part of its commitment to ensuring access to Cortrophin Gel, ANI is creating a patient support program that will include financial assistance for eligible patients. Additional information about this program will become available once the therapy becomes commercially available.