FDA to Review ANI’s Request for Cortrophin Gel Use

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by Somi Igbene, PhD |

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The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticals’ supplemental new drug application for the approval of Cortrophin Gel to treat people with multiple sclerosis (MS) and other chronic inflammatory conditions, including rheumatoid arthritis.

Purified Cortrophin Gel (repository corticotropin injection USP) is a purified adrenocorticotropic hormone (ACTH) that works by stimulating the adrenal cortex to produce cortisol, corticosterone, and aldosterone, among others. These steroids help to reduce inflammation and more rapidly resolve disease relapses or flares.

“FDA’s acceptance of our supplemental new drug application for Cortrophin Gel marks a significant milestone for ANI. With a Prescription Drug User Fee Act target action date of October 29, 2021 we are one step closer to bringing a much-needed product to patients and healthcare providers,” Nikhil Lalwani, CEO of ANI Pharmaceuticals, said in a press release.

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“We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of Cortrophin Gel,” Lalwani added.

The FDA originally approved Cortrophin Gel in 1954 for the treatment of several autoimmune conditions, including MS, rheumatoid arthritis, and nephrotic syndrome, but it was last used in the 1980s.

ANI Pharmaceuticals acquired Cortrophin Gel from Merck in early 2016 and spent more than four years validating the therapy and modernizing its manufacturing and control processes to align with current FDA standards.

After completing the revalidation process in March 2020, ANI sought FDA approval to reintroduce the therapy in the U.S. market. However, in April 2020, the FDA rejected the request, citing concerns with the quality of information provided about the therapy’s chemistry, manufacturing, and control processes.

ANI addressed the concerns highlighted in the refusal letter by the FDA and resubmitted the application, which the agency has now accepted for review.

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