AbbVie Submits Skyrisi to FDA for Crohn’s Disease

AbbVie has submitted an application to the FDA seeking approval for Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate-to-severe Crohn’s disease. Approval is being sought for both the 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy.

The submission is supported by safety and efficacy data from three phase 3 studies – ADVANCE, MOTIVATE and FORTIFY. In these trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these studies were consistent with previous studies.

In the FORTIFY study, a significantly greater proportion of participants achieved the co-primary end points of endoscopic response and clinical remission with Skyrizi subcutaneous maintenance therapy at one year (52 weeks) for both assessed doses (360 mg or 180 mg), compared with those who were randomized to the withdrawal arm and received placebo.

In the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of Skyrizi IV induction therapy (600 mg or 1200 mg) met the co-primary end points of clinical remission and endoscopic response at week 12 compared with placebo.

“While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission,” Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie, said in a statement.

In April 2019, the FDA approved Skyrizi for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Phase 3 trials of Skyrizi in psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing.

Crohn’s disease is a chronic disorder that primarily affects the digestive system. This condition involves an abnormal immune response that causes excess inflammation. It most often affects the intestinal walls, particularly in the lower part of the small intestine and portions of the large intestine. Crohn’s disease is most common in western Europe and North America, where it has a prevalence of 100 to 300 per 100,000 people. More than half a million Americans are currently affected by this disorder.