Prefilled syringe of Cortrophin Gel wins FDA approval
Syringes approved as add-on treatment for sarcoidosis symptoms
The U.S. Food and Drug Administration (FDA) has approved a prefilled syringe version of purified Cortrophin Gel (repository corticotropin injection) as an add-on treatment for people with symptoms of sarcoidosis.
Sold by Ani Pharmaceuticals, the original vial format of Corticotrophin Gel received FDA clearance in 2021 to treat sarcoidosis and several other inflammatory conditions.
With the original format, patients or doctors had to draw the required dosage from the vial into a syringe before administering the injection under the skin or into the muscle. Having prefilled syringes available will make it easier for patients to administer Corticotrophin Gel, according to Ani.
“Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment,” Nikhil Lalwani, president and CEO of Ani, 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 newly approved syringes will contain either 40 units of the therapy in half a milliliter of liquid or 80 units in 1 mL of liquid. Ani plans to make Cortrophin Gel’s new format available through its established specialty pharmacy network by June.
Producing cortisol
Sarcoidosis is an inflammatory disorder marked by abnormal clumps of immune cells, called granulomas, that can form in various organs, causing damage and disrupting organ function. Sarcoidosis treatments generally aim to reduce disease-driving inflammation.
Corticotrophin Gel contains a purified version of the adrenocorticotropin hormone, which triggers the body to produce more cortisol, a hormone with potent anti-inflammatory effects. As such, the therapy is expected to help control symptoms in sarcoidosis and other inflammatory conditions.
The medication, which can be self-administered after training, may be used as an alternative to corticosteroids such as prednisone, which work by mimicking the activity of cortisol and are often used as first-line treatments for inflammatory disorders like sarcoidosis.
Ani offers a patient support program, Cortrophin In Your Corner, that helps patients with prescription support and injection training. Financial support may be available for patients with commercial or government insurance, those with limited insurance, and patients who are uninsured.
Ani’s Cortrophin Gel contains the same active ingredient as Acthar Gel, a medication sold by Mallinckrodt Pharmaceuticals and also approved in the U.S. for sarcoidosis and other inflammatory conditions.
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