FDA approves Cortrophin Gel for use in prefilled syringes
Single-use injection treatment for AS expected to be more convenient
A version of Purified Cortrophin Gel (repository corticotropin injection) that comes in a prefilled syringe has been approved by the U.S. Food and Drug Administration (FDA) for treating ankylosing spondylitis (AS) and other inflammatory diseases.
The injectable treatment from Ani Pharmaceuticals initially was approved in 2021 for a range of conditions, including as a short-term, add-on therapy to help manage acute exacerbations in rheumatic conditions like AS. The medication at the time was available in a vial and had to be drawn into syringes for each injection.
Prefilled syringes are expected to be more convenient to use, as each single-dose treatment is ready for injection. Cortrophin Gel also will continue to be supplied in vials.
Ani plans to make the treatment’s new format available through its established specialty pharmacy network by the close of June, it stated in a company press release.
Cortrophin Gel works to lessen inflammation, helping to control AS flares
“Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment,” said Nikhil Lalwani, Ani’s president and CEO. “This approval reflects our ongoing commitment to addressing the needs of those who rely on Cortrophin Gel therapy.”
AS is a form of arthritis characterized by inflammation that affects the joints of the spine. Patients can experience flares, or exacerbations, where disease symptoms such as pain, stiffness, or fatigue become acutely worse.
Cortrophin Gel is widely used to treat autoimmune and inflammatory diseases. For AS and other forms of arthritis, it is intended as a short-term and add-on therapy for managing flares.
Its main ingredient is a purified version of corticotropin, or adrenocorticotropic hormone (ACTH), along with a complex mix of related protein fragments isolated from pigs.
ACTH is a natural hormone released from the brain’s pituitary gland. It stimulates the adrenal glands atop the kidneys to produce corticosteroids such as cortisol, which have strong anti-inflammatory and immune-suppressing effects.
By easing inflammation, the treatment is expected to help control flares in people with AS and other inflammatory conditions.
Cortrophin Gel comes as a sterile liquid gel that’s injected either under the skin (subcutaneous) or into a muscle (intramuscular). It can be self-administered after proper training.
A version of Cortrophin Gel was approved in the U.S. in the 1950s, and used for decades before being discontinued. Ani acquired the treatment from Merck & Co, its developer, in 2016, and further refined it under more modern quality and manufacturing standards, leading to its FDA approval in 2021.
The therapy works in ways similar to Mallinckrodt’s Acthar Gel, initially given FDA approval to treat AS and other inflammatory conditions in 1952.
Potential side effects of Cortrophin Gel include fluid or salt retention, weight gain, muscle weakness, brittle bones (osteoporosis), stomach ulcers, injection site reactions, impaired wound healing, high blood pressure, convulsions, headache, growth suppression in children, or a Cushingoid state, a collection of symptoms related to cortisol excess.
The Cortrophin In Your Corner patient support program is available to help people navigate the treatment process, including prescription support and injection training. Financial support also may be available for patients with commercial or government insurance, those with limited insurance, and patients who are uninsured.
