AbbVie (ABBV) Submits Application for Risankizumab to the EMA

November 30, 2021 8:06 AM EST

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AbbVie (NYSE: ABBV) today announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab (SKYRIZI®, 600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The submission is supported by three pivotal Phase 3 studies, ADVANCE, MOTIVATE and FORTIFY.1,2

"Patients with moderate to severe Crohn's disease live with challenging symptoms, such as persistent diarrhea and abdominal pain, impacting their quality of life," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "We look forward to working with the regulatory authorities and hope to offer risankizumab as a potential first-in-class treatment option for patients living with this disease."

In the Phase 3 ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with risankizumab IV induction therapy 600 mg achieved both primary endpoints demonstrating statistically significant results for clinical remission and endoscopic response at week 12 compared to placebo.1

In the Phase 3 FORTIFY maintenance study evaluating Crohn's disease patients with clinical response to risankizumab IV induction treatment, a significantly greater proportion of patients treated with risankizumab 360 mg SC achieved endoscopic response and clinical remission at one year (52 weeks) versus those who were withdrawn from risankizumab (control group).2

No new safety risks were observed in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies compared to the known safety profile of risankizumab.1-6

The use of risankizumab for Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

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