ANI Pharmaceuticals Gains FDA Approval of Purified Cortrophin Gel for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome
2 November 2021 - - The US Food and Drug Administration has approved US-based bio-pharmaceutical company ANI Pharmaceuticals, Inc's (NASDAQ: ANIP) supplemental New Drug Application for Purified Cortrophin Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome, the company said.

Cortrophin Gel is an adrenocorticotropic hormone, also known as purified corticotropin.

Cortrophin Gel was first approved in 1954 and used for decades to treat certain chronic autoimmune disorders.

ANI acquired the NDA for Cortrophin Gel from Merck and Co. in 2016.

The company has made a significant investment over the past five years in establishing and updating manufacturing processes and ensuring a sustainable, US-based supply chain.

ANI submitted an sNDA to the FDA in June 2021 to bring Cortrophin Gel back to market for patients, physicians and an overall healthcare system in need of greater access to ACTH therapies.

As part of its commitment to ensuring optimal access to Cortrophin Gel, ANI is investing in and will launch a patient support program including financial assistance such as copay cards, for eligible patients.

Additional details on the program will be provided in conjunction with the commercial launch.
Important Safety Information

ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.