ANI Files Prior Approval Supplement for Purified Cortrophin Gel 80 U/mL

ANI Pharmaceuticals has submitted a prior approval supplement (PAS) to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The current annual market for Cortrophin® Gel is approximately $950 million and has only one competitor. Cortrophin® Gel was originally approved by the FDA in 1954 and last used in patients in the 1980s. Cortrophin® Gel has over 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis.

ANI acquired the NDA for Cortrophin® Gel from Merck in January of 2016 and has spent over four years and over $100 million to re-establish and validate the commercial corticotropin active pharmaceutical ingredient (API) and Cortrophin® Gel drug product manufacturing processes. This effort has included rebuilding a U.S. based supply chain that includes pig pituitaries, replicating and improving the manufacturing process for corticotropin API and drug product, and implementing modernized process controls, analytical methods and process characterization to ensure compliance with current FDA standards.

As part of the PAS, ANI has submitted a comprehensive characterization package which demonstrates an unparalleled understanding of both the API and Cortrophin® Gel. The drug has been proven to meet both historical release specifications, as well as modernized release specifications, to ensure compliance with current FDA process validation, method validation and Quality by Design approaches outlined in ICH Guidelines Q8/Q9/Q10. "We are very pleased to have submitted this PAS on schedule and in hopes of bringing Cortrophin® Gel back to the market for both patients and physicians," said Dr. Mark Ginski, Vice President of Corticotropin Development for ANI.

ANI's Cortrophin® Gel re-commercialization effort represents a unique opportunity to re-introduce much needed competition, patient and physician choice and substantial drug cost savings into a U.S. corticotropin market currently monopolized by Mallinckrodt's H.P. Acthar® Gel. At one point in the mid to late 20th century, there were over a half-dozen approved and active corticotropin NDAs; however, all other NDAs, except for ANI's Cortrophin® Gel and Cortrophin® Zinc, have been withdrawn and are no longer marketed. In addition, a number of potential competitors who were developing synthetic corticotropin products have since ceased development.

The FDA has a four-month PDUFA requirement to respond to ANI's application and determine whether the Cortrophin® Gel PAS submission is complete and acceptable for approval.

Purified Cortrophin® Gel has 54 indications on its previously approved label. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

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