The submissions to both the FDA and the EMA are supported by two phase 3 trials demonstrating Skyrizi achieved the primary endpoint of clinical remission.
AbbVie has submitted applications to the FDA and to European Medicines Agency (EMA) for a new indication for Skyrizi (risankizumab) to treat adult patients with moderately to severely active ulcerative colitis.
Ulcerative colitis is a chronic, immune-related inflammatory bowel disease. Between 600,000 and 900,000 people in the United States have ulcerative colitis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Ulcerative colitis can lead to complications, including anemia, bone problems, and colorectal cancer.
Skyrizi blocks interleukin-23, a cytokine involved in inflammatory processes and is thought to be linked to a number of chronic immune-mediated diseases. Developed through a collaboration between Boehringer Ingelheim and AbbVie, Skyrizi is already available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The list price for one dose of Skyrizi is $19,734.61. Patients with commercial insurance are eligible for a $5 copay card four times a year. The copay card assistance has a limit of $1,000, and patients whose PBM or insurance company includes an accumulator or maximizer program are not eligible for assistance. AbbVie indicates that Skyrizi is preferred on more 95% of national insurance coverage and 97% on Medicare Part D, as of May 2023.
The applications for the ulcerative colitis indication were supported by data from two phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND. Significantly more patients treated with Skyrizi in the induction study and at week 52 in the maintenance study achieved the primary endpoint of clinical remission compared with patients receiving placebo. Additionally, more Skyrizi-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement.
In the COMMAND study, which was released in July 2023, 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360 mg achieved endoscopic improvement at week 52 versus 32% of patients in the induction-only control group. Additionally, a significantly higher proportion of patients who received Skyrizi achieved steroid-free clinical remission compared with the induction-only control group at week 52.
In the INSPIRE study, which was released in March 2023, 36% of patients treated with Skyrizi achieved endoscopic improvement at week 12 compared with 12.1% in patients who received placebo. Additionally, 20.3% of patients receiving Skyrizi achieved clinical remission compared with 6.2% of patients receiving placebo.