Cortrophin Gel Now Widely Available in US for Acute Relapses

ANI Pharmaceuticals has announced the full U.S. commercial availability of Cortrophin Gel (repository corticotropin injection), an injectable therapy approved for managing acute relapses in people with multiple sclerosis (MS) and other autoimmune disorders.

“Patients with certain chronic autoimmune conditions often need additional treatment options,” Mary Pao Seideman, MD, PhD, ANI’s chief medical officer, said in a press release, adding that “choice in [this treatment] category is long overdue.”

Besides MS, the therapy — comprised of corticotropin, or adrenocorticotropic hormone (ACTH), which is known to have anti-inflammatory effects — is approved for rheumatoid arthritis, as well as allergic and inflammatory diseases.

Cortrophin Gel is now available through a network of specialty pharmacies and distributors in the U.S. To gain access to the therapy, eligible patients, together with their physicians, can fill out and submit the Cortrophin Gel Enrollment Form (with prescription).

The announcement marks the relaunch of Cortrophin Gel, which was first approved in the U.S. in 1954 for multiple autoimmune diseases, but fell out of use in the 1980s. Since then, Mallinckrodt Pharmaceuticals’ Acthar Gel — likewise indicated for MS attacks, and other autoimmune conditions — was the only repository corticotropin injection available in the U.S.

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“With today’s full-scale commercial launch of Cortrophin Gel, an established treatment, healthcare professionals now have another ACTH therapy option, with U.S.-based development, supply chain and manufacturing,” said Nikhil Lalwani, president and CEO of ANI.

Cortrophin Gel’s relaunch “is the culmination of six years of hard work and dedication from ANI employees and external partners, building on ANI’s long history and mission to create high-quality medicines for patients in need,” Lalwani added.

Christopher Mutz, ANI’s head of rare diseases, said: “Our goal from the start has been to ensure that Cortrophin Gel is available to as many patients who need it as possible.”

“As part of our commitment to supporting meaningful access to Cortrophin Gel, we’ve launched our reimbursement and access support hub, Cortrophin in Your Corner to provide commercial copay support and other reimbursement assistance for eligible patients,” Mutz added.

According to the program’s website, eligible commercially insured patients may get the gel for as little as $0 per prescription fill within the copay savings program. Those without insurance or with government-insured plans may still be eligible for financial support.

The Cortrophin in Your Corner program also helps coordinate home delivery of the therapy and provides Cortrophin Gel injection training from a certified nurse at no cost. To know more about the program, patients and caregivers may call 1-800-805-5258.

ANI acquired the rights for Cortrophin Gel from Merck (known as MSD outside North America) in 2016.

The gel, which can be injected either under the skin (subcutaneously) or into the muscle, contains purified ACTH, which stimulates the production of a stress hormone called cortisol by the adrenal glands, located on top of the kidneys.

Like corticosteroids, medications that closely resemble the naturally produced cortisol, Cortrophin Gel is expected to help reduce inflammation and more rapidly resolve inflammation-induced relapses in MS.

Importantly, the medication is not indicated for people with conditions such as low bone density, stomach ulcers, heart failure or high blood pressure, specific infections, abnormal functioning of the adrenal glands, or a chronic skin condition called scleroderma.