ANI Pharmaceuticals announced the FDA approval of 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.”
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