Stelara Receives FDA Approval for the Treatment of Crohn's Disease

It is the first biologic that targets interleukin-12 and interleukin-23 cytokines active in the disease

Ustekinumab (Stelara, Janssen Biotech, Inc.) has been approved by the FDA for the treatment of moderately to severely active Crohn's disease in adults (18 years of age or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.

Ustekinumab is the first biologic therapy for Crohn's disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses.

"Crohn's disease is a complex condition to treat, and not all therapies work for every patient," said William J. Sandborn, MD, Chief of the Division of Gastroenterology, and Professor of Medicine at the University of California San Diego School of Medicine, and study investigator. "The FDA approval of Stelara represents an important advancement in treating patients with Crohn's disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn's disease."

In clinical studies of patients who were either new to, experienced with, or failed biologic therapy (TNF blockers), between 34% (UNITI-1 study) and 56% (UNITI-2 study) of patients experienced relief from their Crohn's disease symptoms within six weeks after receiving the one-time intravenous (IV) infusion of ustekinumab. Noticeable improvement was observed as early as three weeks. Additionally, the majority of those who responded to induction dosing and continued treatment with ustekinumab subcutaneous maintenance doses every eight weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose).

Ustekinumab is the only treatment for Crohn's disease that starts with a weight-based, one-time IV infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90-mg subcutaneous maintenance injections every eight weeks to help keep the symptoms under control. The first dose of ustekinumab (the induction dose) is administered under the supervision of a health care professional. Subsequent maintenance doses are administered either by a health care professional or self-injected by the patient after proper training.

Janssen reports that it will work closely with payers, providers, and pharmacy benefit managers to ensure ustekinumab is broadly accessible and affordable for patients, and that the cost for payers is competitive with currently available biologic therapies for Crohn's disease. The company offers a number of patient support programs, including a copay card for patients with commercial insurance that reduces their out-of-pocket cost for ustekinumab to no more than $5 per dose (IV and/or subcutaneous injection), which is also offered for patients with psoriasis and psoriatic arthritis.

Source: PR Newswire; September 26, 2016.