AbbVie has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for a new indication of risankizumab (SKYRIZI) to treat moderately to severely active ulcerative colitis.
The new indication is for risankizumab 1,200mg intravenous (induction dose) and 180mg and 360mg subcutaneous (maintenance dose).
AbbVie’s applications are supported by results from two Phase III clinical trials, including INSPIRE, an induction study; and COMMAND, a maintenance study.
The primary endpoint of clinical remission was met in patients who received risankizumab 1,200mg IV at week 12 in the induction study, and 180mg or 360mg SC at week 52 in the maintenance study.
Patients treated with risankizumab in both studies achieved the key secondary endpoints of endoscopic improvement as compared to placebo.
No new safety risks were observed and the safety results in INSPIRE and COMMAND were generally consistent with the safety profile of risankizumab.
AbbVie chief medical officer and development, regulatory affairs senior vice-president Roopal Thakkar stated: “While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects.
“These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis.”
Risankizumab is an IL-23 inhibitor currently approved by the FDA and the EMA for Crohn’s disease, psoriatic arthritis and psoriasis.
It has been developed as part of a collaboration between Boehringer Ingelheim and AbbVie, which is leading development and commercialisation worldwide.
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