Agency gives green light to supplemental new drug application for repository corticotropin injection.
The FDA has approved the supplemental new drug application for repository corticotropin injection (Purified Cortrophin Gel, ANI Pharmaceuticals) for the treatment of chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary problems, because of nephrotic syndrome, ANI said in a statement.
“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,” Nikhil Lalwani, chief executive officer and president of ANI Pharmaceuticals, said in the statement.
“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 US-based development and manufacturing,” Lalwani said.
“We anticipate a full-scale commercial launch by early in the first quarter of 2022,” he said.
Repository corticotropin injection is an adrenocorticotropic hormone known as purified cortophin.
Adverse events include fluid or sodium retention, impaired wound healing, muscle weakness, osteoporosis, and peptic ulcer with possible perforation hemorrhage.
The repository corticotropin injection was first approved to be used to treat other chronic autoimmune disorders in 1954.
ANI Pharmaceuticals announces FDA approval of purified cortrophin gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome. Businesswire. News release. November 1, 2021. Accessed November 2, 2021. https://www.businesswire.com/news/home/20211101005292/en