Research & Development
ANI Pharmaceuticals submits prior approval supplement for Purified Cortrophin Gel in 80 U/ml to FDA
25 March 2020 -

Pharmaceutical company ANI Pharmaceuticals Inc (Nasdaq:ANIP) said on Tuesday that it has filed for prior approval supplement (PAS) with the US FDA's Endocrinology Division for re-launch of Purified Cortrophin Gel (Repository Corticotropin Injection USP) in 80 U/ml.

According to the company, 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.

Under the terms of the PAS, the FDA has a four-month PDUFA requirement to respond to the company's application and determine whether the Cortrophin Gel PAS submission is complete and acceptable for approval. It has submitted a comprehensive characterization package and the drug has been proven to meet both historical release specifications, as well as modernized release specifications.

In addition, the current annual market for Cortrophin Gel is approximately USD950m with only one competitor.

The company added that it acquired the Cortrophin Gel NDA from Merck and has spent four years and over USD100m to re-establish and validate the commercial corticotropin active pharmaceutical ingredient (API) and Cortrophin Gel drug product manufacturing processes.

The company's objective is to introduce direct competition into this USD950m monopoly and reduce drug costs for the US Government, specifically Medicare and Medicaid, which is responsible for approximately 60% of corticotropin spend.