The U.S. Food & Drug Administration (FDA) has approved Purified Cortrophin Gel (repository corticotropin injection USP) to treat multiple sclerosis (MS) relapses in adults. The medication, produced by ANI Pharmaceuticals, can serve as an alternative to corticosteroids, which are commonly prescribed for acute MS relapses (or exacerbations).
Though effective in treating some MS relapses, corticosteroids are sometimes difficult for people to tolerate. They can have undesirable side effects, including organ damage. Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin. ACTH stimulates the adrenal cortex gland to naturally secrete corticosteroid hormones — cortisol, corticosterone, and aldosterone — to control inflammation.
“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 Dr. Mary Pao Seideman, chief medical officer of ANI Pharmaceuticals, in a statement. “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.”
The other ACTH treatment on the market for MS is called H.P. Acthar Gel (repository corticotropin injection).
Cortrophin Gel was initially approved in the U.S. in the 1950s to treat a variety of autoimmune conditions, but the new approval for treating MS relapses is part of a supplemental New Drug Application filed by manufacturer ANI Pharmaceuticals. The drug is also now approved for people with rheumatoid arthritis and nephrotic syndrome.
“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, CEO and president of ANI Pharmaceuticals, in a news release.
Clinical trials have demonstrated Cortrophin Gel’s effectiveness at resolving acute MS exacerbations, according to the prescribing information about the treatment. Potential side effects include muscle weakness, osteoporosis, stomach ulcers with possible bleeding, impaired wound healing, high blood pressure, convulsions, and headache. It also may increase a person’s chances of an infection.
ANI plans to make the medication available to people with these diagnoses in early 2022, according to the company’s news release. In addition, ANI will roll out a support program offering financial assistance for people who are eligible. This may include such offerings as copay cards, and the program will launch when the product comes to market early next year.
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