AbbVie has sought approval from the European Medicines Agency (EMA) for risankizumab (Skyrizi, 600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), to treat patients who are 16 years and above suffering with moderate to severe active Crohn's disease.
An interleukin-23 (IL-23) inhibitor, Risankizumab is intended to treat patients with Crohn’s disease who have shown insufficient response, lost response or are intolerant to biologic or conventional treatment.
A chronic, systemic disease, Crohn’s disease manifests as inflammation within the gastrointestinal tract, and causes continuous diarrhea and abdominal pain.
US-based AbbVie’s submission to the EMA is backed by three important Phase III studies – ADVANCE, MOTIVATE and FORTIFY.
AbbVie chief scientific officer senior vice president of research and development Tom Hudson said: “Patients with moderate to severe Crohn’s disease live with challenging symptoms, such as persistent diarrhea and abdominal pain, impacting their quality of life.
“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.”
It was found in the Phase III ADVANCE and MOTIVATE induction trials that a significantly greater proportion of patients treated with risankizumab IV induction therapy of 600mg met both the primary endpoints,and showed statistically significant results for clinical remission and endoscopic response at week 12 as against placebo.
The two primary goals were achievement of clinical remission and endoscopic response at week 12.
The ADVANCE and MOTIVATE trials are Phase 3, multicentre, randomised, double-blind, placebo-controlled induction studies intended to analyse the efficacy and safety of two doses of Risankizumab – 600mg and 1200mg in patients as against placebo.
In the Phase III FORTIFY maintenance trial analysing Crohn’s disease patients with clinical response to risankizumab IV induction treatment, it was found that a significantly greater proportion of patients treated with risankizumab 360mg SC met endoscopic response and clinical remission at one year (52 weeks) as against those patients who were withdrawn from risankizumab (control group).
A Phase 3, multicentre, randomised, double-blind, control group, 52-week maintenance study, FORTIFY is intended to analyse the efficacy and safety of risankizumab 180mg and 360mg as maintenance therapy against withdrawal in patients who responded to risankizumab induction treatment in the ADVANCE and MOTIVATE studies.
There were no new safety risks in moderate to severe Crohn’s disease in the ADVANCE, MOTIVATE and FORTIFY trials compared to the known safety profile of risankizumab.
The use of risankizumab for treating Crohn’s disease is not approved, while its safety and efficacy have not been established by regulatory bodies.
Risankizumab (Skyrizi) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie being responsible for leading its development and commercialisation across the globe.