FDA Approves STELARA-ustekinumab For Treatment of Active Crohn's Disease

Janssen Biotech, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved STELARA^® (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adults (18 years 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. STELARA^® 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, Division of Gastroenterology, and Professor of Medicine, UC 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 in just six weeks after receiving the one-time intravenous (IV) infusion of STELARA^®. Noticeable improvement was observed as early as three weeks. Additionally, the majority of those who responded to induction dosing and continued treatment with STELARA^®subcutaneous maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose).

STELARA^® is the only treatment for Crohn's disease that starts with a weight based, one time intravenous (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 8 weeks to help keep the symptoms under control. The first dose of STELARA^® is an induction dose, administered intravenously, under the supervision of a healthcare professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a healthcare professional or self-injected by the patient after proper training.

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

"The approval of STELARA^® for Crohn's disease underscores our commitment to provide innovative treatment options for people living with chronic inflammatory and immune mediated diseases," said Andrew Greenspan, MD, vice president of medical affairs at Janssen Biotech, Inc. "We are confident STELARA^® will improve the lives of many people living with Crohn's disease and are committed to ensuring that it is accessible to patients who qualify for this new therapeutic option."

Clinical Trial Program

The clinical development program for STELARA^® for Crohn's disease included more than 1,300 patients across three pivotal Phase 3 studies, which served as the primary basis for FDA approval.

• The UNITI-1 induction study found that treatment with STELARA^® induced clinical response and clinical remission in patients who had previously failed or were intolerant to treatment with one or more TNF blockers.


• The UNITI-2 induction study demonstrated treatment with STELARA^® induced clinical response and clinical remission in patients who had previously failed or were intolerant to conventional therapy (immunomodulators or corticosteroids), the majority of whom were naïve to treatment with a TNF blocker.


• The IM-UNITI maintenance study, which evaluated patients who achieved clinical response eight weeks after a single intravenous infusion of STELARA^® in the UNITI-1 and UNITI-2 Phase 3 induction studies, demonstrated that more than half of patients receiving STELARA^® subcutaneous injections every eight weeks were in clinical remission after nearly one year of treatment.