The European Commission has granted approval for AbbVie’s Skyrizi (risankizumab) to be used in the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
This approval applies to those who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy.
According to AbbVie, the recommended induction dose of Skyrizi is 1,200mg, administered via intravenous (IV) infusion at week 0, week 4, and week 8.
For maintenance, starting at week 12 and continuing every eight weeks thereafter, the recommended dose is either 180mg or 360mg, administered via subcutaneous (SC) injection, depending on the individual patient’s presentation.
The EC approval is based on data from two Phase 3 clinical trials, INSPIRE and COMMAND.
In the INSPIRE induction trial, a significantly higher proportion of patients treated with risankizumab 1,200mg IV achieved the primary endpoint of clinical remission, as measured by the Adapted Mayo Score, at week 12 compared to those receiving a placebo (20% vs 6%).
The COMMAND maintenance trial showed that a significantly higher proportion of patients receiving risankizumab 180mg or 360mg SC achieved clinical remission at week 52 compared to the induction-only control group, with remission rates of 40% and 38%, respectively, versus 25%.
AbbVie chief scientific officer and research and development executive vice president Roopal Thakkar said: “The approval of SKYRIZI for the treatment of UC provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use, including conventional or biological therapy.
“Notably, in the Phase 3 trials we observed positive results in mucosal healing particularly in patients without previous biologic experience or JAK inhibitor failure.
“The EU approval of Skyrizi for people living with UC strengthens our diversified IBD portfolio, providing healthcare professionals with more options to treat their IBD patients.”
Skyrizi is an interleukin (IL)-23 inhibitor, selectively blocking IL-23 by binding to its p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is associated with several chronic immune-mediated diseases.
The IL-23 inhibitor is also approved by the US Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Skyrizi is the result of a collaboration between Boehringer Ingelheim and AbbVie announced in 2016. The latter has been leading the asset’s global development and commercialisation.
