{"id":787278,"date":"2023-10-02T07:07:33","date_gmt":"2023-10-02T11:07:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-fda-approval-and-commercial-availability-of-new-1-ml-vial-size-of-purified-cortrophin-gel-appropriate-for-adjunctive-treatment-of-certain-patients-with-acute-gout\/"},"modified":"2023-10-02T07:07:33","modified_gmt":"2023-10-02T11:07:33","slug":"ani-pharmaceuticals-announces-fda-approval-and-commercial-availability-of-new-1-ml-vial-size-of-purified-cortrophin-gel-appropriate-for-adjunctive-treatment-of-certain-patients-with-acute-gout","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-fda-approval-and-commercial-availability-of-new-1-ml-vial-size-of-purified-cortrophin-gel-appropriate-for-adjunctive-treatment-of-certain-patients-with-acute-gout\/","title":{"rendered":"ANI Pharmaceuticals Announces FDA Approval and Commercial Availability of New 1-mL Vial Size of Purified Cortrophin\u00ae Gel, Appropriate for Adjunctive Treatment of Certain Patients with Acute Gouty Arthritis Flares"},"content":{"rendered":"
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\n Cortrophin Gel is the only FDA-approved purified corticotropin (ACTH) indicated for the treatment of appropriate patients with acute gouty arthritis flares<\/em>\n <\/p>\n

\n New 1-mL size furthers ANI\u2019s commitment to providing ACTH options for appropriate acute gouty arthritis flare patients and their healthcare providers; available through distributors to help enable in-office administration and through specialty pharmacies<\/em>\n <\/p>\n

\n Cortrophin Gel will now be available in two sizes, including the 5-mL vial size launched in January 2022<\/em>\n <\/p>\n

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BAUDETTE, Minn., Oct. 02, 2023 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and commercial availability of a 1-mL vial (80 USP units\/1 mL) of Purified Cortrophin\u00ae\u00a0Gel (repository corticotropin injection USP) (Cortrophin Gel). The 1-mL vial is now available via Cortrophin Gel\u2019s existing specialty pharmacy network and will also be available for ordering via national specialty distributors. Cortrophin Gel is already available in a 5-mL vial. Cortrophin Gel is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis. Cortrophin Gel is contraindicated for intravenous administration. For additional important safety information, please see below.<\/p>\n

ANI reintroduced Cortrophin Gel to the market in January 2022. At that time, Cortrophin Gel became the first newly commercialized drug indicated for appropriate patients with acute gouty arthritis flares in 12 years. This smaller 1-mL product configuration was developed with the goal of helping enable rapid time to therapy, at point-of-care, for appropriate patients with acute gouty arthritis flares.<\/p>\n

“More than 9 million people in the US are affected by gout, and each year a portion of these patients experience acute gouty arthritis flares as a symptom of their underlying disease. For some of these patients, Cortrophin Gel may be an appropriate additional treatment option for their flares. The approval of the 1-mL vial for Cortrophin Gel is another step forward in our mission to increase access for appropriate acute gouty arthritis flare patients in need. Scaling up our Rare Disease business is ANI\u2019s largest growth driver and key to achieving our goal of building a high-growth biopharma company,\u201d stated Nikhil Lalwani, President and Chief Executive Officer of ANI.<\/p>\n

\u201cWith this approval, we look forward to continuing the Cortrophin Gel launch momentum we have seen to date,\u201d Lalwani continued. \u201cThe commercial launch of the 1-mL vial will be supported by ANI\u2019s existing Cortrophin Gel field sales force, which is already engaging rheumatologists and nephrologists who treat patients with acute gouty arthritis flares. Importantly, we are enhancing Cortrophin in Your Corner\u2122<\/em>, our reimbursement and access hub, to include support for this new 1-mL configuration of Cortrophin Gel.\u201d<\/p>\n

\u201cGout is the most common type of inflammatory arthritis,\u201d said Mary Pao, MD, PhD, Chief Medical Officer of ANI. \u201cAcute gouty arthritis flare patients who are in need of an additional flare treatment options, beyond currently recommended first line therapies, have a need for alternatives. The development of the 1-mL vial represents ANI\u2019s commitment to this patient population.\u201d<\/p>\n

Cortrophin Gel is an adrenocorticotropic hormone (ACTH), also known as purified corticotropin, and it is approved 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 the only FDA-approved ACTH therapy indicated for the treatment of appropriate patients with acute gouty arthritis flares. For a full list of indications, please see below.<\/p>\n

\n Indications<\/strong>\n <\/p>\n

Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for:<\/p>\n