- The U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotrophin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome.
- Cortrophin Gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. This approval re-introduces much-needed patient and physician choice into the U.S. repository corticotropin market.
- Rheumatoid Arthritis, a chronic inflammatory disorder affecting many joints, including those in the hands and feet.
- Multiple Sclerosis, a disease in which the immune system eats away at the protective covering of nerves
- Nephrotic Syndrome, a kidney disorder that causes the body to excrete too much protein in the urine.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin.
“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, President and Chief Executive Officer of ANI Pharmaceuticals. “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. We anticipate a full-scale commercial launch by early in the first quarter of 2022.”
“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 Mary Pao Seideman, MD, Ph.D., Chief Medical Officer of ANI Pharmaceuticals. “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.”
Cortrophin Gel was first approved in 1954 and used for decades to treat certain chronic autoimmune disorders. ANI acquired the NDA for Cortrophin Gel from Merck & Co. in 2016. The Company has made a significant investment over the past five years in establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain. ANI submitted an NDA to the FDA in June 2021 to bring Cortrophin Gel back to the market for patients, physicians, and an overall healthcare system in need of greater access to ACTH therapies.
As part of its commitment to ensuring optimal access to Cortrophin Gel, ANI is investing in and will launch a patient support program including financial assistance such as copay cards, for eligible patients. Additional details on the program will be provided in conjunction with the commercial launch.
This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system’s response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions.
What are corticotophins?
Adrenocorticotropic hormone (ACTH; also adrenocorticotropin, corticotropin) is a polypeptide tropic hormone produced by and secreted by the anterior pituitary gland. It is also used as a medication and diagnostic agent. ACTH is an important component of the hypothalamic-pituitary-adrenal axis and is often produced in response to biological stress (along with its precursor corticotropin-releasing hormone from the hypothalamus). Its principal effects are increased production and release of cortisol by the cortex of the adrenal gland. ACTH is also related to the circadian rhythm in many organisms.
Corticotropin acts through the stimulation of cell surface ACTH receptors, which are primarily located on the adrenocortical cells. Corticotropin stimulates the cortex of the adrenal gland and boosts the synthesis of corticosteroids, mainly glucocorticoids but also sex steroids (androgens).
Uses of Cortotophin:
This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system’s response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. Corticotropin is a hormone.
Important Safety Information
- Cortrophin Gel is contraindicated for intravenous administration.
- Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources.
Warnings and Precautions
- Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.
- Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.
- Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.
- Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of the disease.
- Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.
- Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.
- Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
- Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.
- Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.
- Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.
- Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.
- Growth and development: Carefully observe the growth and development of infants and children on prolonged corticotropin therapy.
- Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.
- Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.
- Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; and suppression of growth in children. These are not all the adverse reactions reported with Cortrophin Gel.
Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:
- Short-term administration as an adjunctive therapy during an acute episode or exacerbation in rheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; and acute gouty arthritis.
- Exacerbations or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).
- Severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.
- Atopic dermatitis and serum sickness.
- Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis, and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.
- Symptomatic sarcoidosis.
- Inducing a diuresis or remission of proteinuria due to nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
What is Rheumatoid Arthritis?
A chronic inflammatory disorder affecting many joints, including those in the hands and feet.
In rheumatoid arthritis, the body’s immune system attacks its own tissue, including joints. In severe cases, it attacks internal organs.
Rheumatoid arthritis affects joint linings, causing painful swelling. Over long periods of time, the inflammation associated with rheumatoid arthritis can cause bone erosion and joint deformity.
While there’s no cure for rheumatoid arthritis, physiotherapy and medication can help slow the disease’s progression. Most cases can be managed with a class of medications called anti-rheumatic drugs (DMARDS)
What is Multiple Sclerosis?
A disease in which the immune system eats away at the protective covering of nerves.
In MS, resulting nerve damage disrupts communication between the brain and the body.
Multiple sclerosis causes many different symptoms, including vision loss, pain, fatigue, and impaired coordination. The symptoms, severity, and duration can vary from person to person. Some people may be symptom-free for most of their lives, while others can have severe, chronic symptoms that never go away.
Physiotherapy and medication that suppress the immune system can help with symptoms, and slow disease progression.
What is Nephrotic Syndrome?
A kidney disorder that causes the body to excrete too much protein in the urine.
Nephrotic syndrome is often caused by damage to small blood vessels in the kidneys that filter waste and excess water from the blood. An underlying health condition usually plays a role.
Symptoms include swelling around the eyes and in the feet and ankles, foamy urine, and weight gain due to excess fluid retention.
Treatment addresses underlying conditions and might include blood pressure medication and water pills.
About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.
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