ANI Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin.

“FDA’s approval of Cortrophin Gel enables us to bring a much-needed treatment choice to patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis as well as nephrotic syndrome, who are coping with a devastating disease on a daily basis,” said Nikhil Lalwani, President and Chief Executive Officer of ANI Pharmaceuticals. “We are pleased to offer Cortrophin Gel, an established treatment, to provide another option to patients and prescribers. This approval reflects ANI’s commitment to the patients and physicians we serve, combined with U.S.-based development and manufacturing. We anticipate a full-scale commercial launch by early in the first quarter of 2022.”

“Patients who are refractory or intolerant to corticosteroids have an especially urgent need for effective alternatives and are at risk of ongoing organ damage with long-term disease,” said Mary Pao Seideman, MD, PhD, Chief Medical Officer of ANI Pharmaceuticals. “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.”

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 & 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, U.S.-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.