FDA approves prefilled syringe formulation of Ani’s Cortrophin Gel
In MS, approval should ease use of purified gel for treating relapses
The U.S. Food and Drug Administration (FDA) has approved a prefilled syringe format for Ani Pharmaceuticals’ purified Cortrophin Gel that’s expected to reduce the number of steps needed for administering the therapy — used in multiple sclerosis (MS) to treat relapses.
The approval means that people with conditions for which purified Cortrophin Gel is approved, including MS patients experiencing a relapse, now have a more convenient administration option.
“Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment,” Nikhil Lalwani, president and CEO of Ani Pharmaceuticals, said in a company press release. “This approval reflects our ongoing commitment to addressing the needs of those who rely on Cortrophin Gel therapy.”
The new formulation will be available in two dosages — 40 USP units/0.5 mL and 80 USP units/1.0 mL — that patients can give themselves via subcutaneous, or under-the-skin, injections.
Cortrophin Gel will remain available as 5 mL and 1 mL multiple-dose vials. With this formulation, patients can also self-administer the therapy after appropriate training, but they must draw precise amounts of the medication before administering it.
New prefilled syringe formulation reduces number of steps for therapy’s use
According to the company, the prefilled syringes should become available in the coming months through Cortrophin Gel’s established specialty pharmacy network. A prefilled syringe formulation also became available last year for Acthar Gel, a similar medication that’s also used to manage relapses in people with MS.
“We look forward to making the Cortrophin Gel prefilled syringe available in the second quarter of 2025,” or by the end of June, Lalwani said.
Cortrophin Gel is an injection medication that’s approved for a number of inflammatory and autoimmune diseases, such as lupus, psoriasis, arthritis, and sarcoidosis. It’s also indicated for managing acute MS relapses, which are periods in which new symptoms appear or old ones worsen.
The therapy contains a small fragment of the adrenocorticotropic hormone, a naturally occurring hormone that boosts the production of cortisol. Cortisol is an anti-inflammatory hormone that can reduce the activity of the immune system, easing the inflammation that occurs during a relapse. This is expected to ease symptoms and speed recovery during a relapse.
We look forward to making the Cortrophin Gel prefilled syringe available in the second quarter of 2025 [or by the end of June].
Cortrophin Gel is generally considered only for MS patients who do not respond to more conventional therapies, and can be administered via intramuscular, or into-the-muscle, or subcutaneous injections. The recommended dosing regimen is 80 to 120 USP, given daily for two to three weeks.
With the new approval, patients can now choose the most convenient method of administration for them, according to the company. If the prefilled syringe option is the preferred method, the therapy should be administered subcutaneously in the stomach or upper thigh regions, or in the upper arm if given by a caregiver. More than one prefilled syringe may be needed to administer an individual’s full dose.
If the older, vial-and-syringe formulation is selected, intramuscular or subcutaneous administration can be considered depending on the doctor’s directions. For this option, patients or caregivers will have to draw the exact amount of the medication from the vial.
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