FDA approves Cortrophin Gel for rheumatoid arthritis, multiple sclerosis
Click Here to Manage Email Alerts
The FDA has approved a supplemental new drug application for ANI Pharmaceutical’s Cortrophin Gel to treat rheumatoid arthritis, multiple sclerosis and certain other autoimmune diseases, according to a company press release.
The FDA decision clears the way for the adrenocorticotropic hormone (ACTH), also known as purified corticotropin, to reenter the U.S. market for the first time since the 1980s. Cortrophin Gel first gained FDA approval in 1954, and included more than 54 indications over the subsequent decades.
“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, president and CEO of ANI Pharmaceuticals, said in the company release. “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,” Lalwani added. “We anticipate a full-scale commercial launch by early in the first quarter of 2022.”
Cortrophin Gel, injected subcutaneously or intramuscularly, is indicated for short-term adjunctive therapy for an acute exacerbation of RA, psoriatic arthritis, ankylosing spondylitis and gouty arthritis; as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis; in severe erythema multiforme and severe psoriasis; atopic dermatitis and serum sickness; severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa; symptomatic sarcoidosis; inducing diuresis or proteinuria remission related to nephrotic syndrome without uremia of the idiopathic type; and acute exacerbations of multiple sclerosis.
ANI acquired the NDA for Cortrophin Gel from Merck & Co. in 2016 and, according to reports, invested more than $100 million to reintroduce the product. The company filed for FDA approval in 2020 but was turned away over concerns related to chemistry, manufacturing and controls section. ANI later resubmitted its application in June.
“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,” Mary Pao Seideman, MD, PhD, chief medical officer for ANI Pharmaceuticals, said in the company release. “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.”
Read more about
Click Here to Manage Email Alerts