Regulatory Decision Summary for Skyrizi

After evaluation of the submitted data package, Health Canada, pursuant to section C.08.004 of the Food and Drugs Regulations, authorized Skyrizi (risankizumab) for the following new indication:

“The treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.”

Skyrizi previously received market authorization for the treatment of Crohn’s disease, active psoriatic arthritis, and plaque psoriasis. Please refer to the product monograph for Skyrizi for more information.

Ulcerative Colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by recurring episodes of inflammation limited to the mucosal layer of the colon and rectum. This inflammation can cause severe bleeding, toxic megacolon, fulminant colitis, and perforation. Skyrizi (risankizumab) is a humanized IgG1 antibody that binds to human interleukin 23 (IL-23) cytokine. IL-23 is involved in inflammatory and immune responses, which contribute to Ulcerative Colitis (UC). As a result, by binding to IL-23, Skyrizi helps to reduce chronic inflammation through pharmacotherapy treatment.

Authorization was based on two pivotal studies designed to evaluate the efficacy and safety of Skyrizi as an induction treatment (induction phase study) and as a maintenance treatment in subjects who achieved clinical response during the previous induction study (maintenance phase study). The induction dose was 1,200 mg administered by intravenous infusion at Week 0, Week 4, and Week 8. The maintenance dose administered was either 180 mg or 360 mg administered subcutaneously every 8 weeks, beginning 4 weeks after the last intravenous Skyrizi administration.

The primary efficacy endpoint in the induction phase study and the maintenance phase study was the proportion of subjects in clinical remission at Week 12 and Week 52, respectively. Key secondary endpoints included the proportion of subjects in clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement. Corticosteroid-free clinical remission was an additional key secondary endpoint in the maintenance phase study. There was a statistically significant and clinically meaningful benefit for Skyrizi compared to placebo for these endpoints.

The safety profile of Skyrizi in patients with UC was consistent with the other authorized indications. There were no new risks or serious safety concerns identified, and the incidence of adverse events (AEs) was low.

Overall, the benefit-risk profile of Skyrizi used in the treatment of patients with Ulcerative Colitis (UC) is deemed favourable.

An updated Risk Management Plan (RMP) for Skyrizi was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Skyrizi has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Skyrizi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.