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AbbVie Seeks New Approval for Risankizumab from FDA and EMA


29 August 2023

AbbVie has applied to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for a new indication of risankizumab (Skyrizi) for treating moderately to severely active ulcerative colitis. The focus is on risankizumab's induction and maintenance doses, which are supported by results from the INSPIRE and COMMAND trials. 

Roopal Thakkar, MD, at AbbVie emphasized the need for more ulcerative colitis treatments and the company's dedication to those with IBD. Risankizumab, an interleukin-23 inhibitor, is currently approved for treating plaque psoriasis, psoriatic arthritis, and Crohns disease but awaits approval for ulcerative colitis. 

Pharmaceutical company AbbVie has submitted applications to both FDA and EMA for an expanded use of risankizumab. The move aims to have the drug, currently approved for conditions like Crohn’s disease, psoriatic arthritis, and psoriasis, recognized for the treatment of moderate to severe ulcerative colitis. 

The applications are underpinned by data from two pivotal Phase III clinical trials: INSPIRE, which focuses on induction, and COMMAND, a maintenance study. Positive results showed that patients receiving risankizumab achieved clinical remission and crucial secondary outcomes, notably endoscopic improvements when compared to a placebo group.

"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," said Roopal Thakkar, M.D., senior vice president at AbbVie, "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."

Safety outcomes from the trials echo the known safety profile of risankizumab, with no unforeseen risks identified. The development of risankizumab is the result of a collaborative project between Boehringer Ingelheim and AbbVie, with the latter leading the charge in global development and commercialization efforts.

About Risankizumab

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 

SKYRIZI is approved by the FDA and the EMA for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. The use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. 

About COMMAND Maintenance Study

The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study.


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