Regulatory Decision Summary for Skyrizi

Plaque psoriasis is a common chronic, immune-mediated, inflammatory skin disease with significant effect on quality of life that typically presents with red, scaly patches of skin that are frequently itchy and painful.

Skyrizi (risankizumab injection) is an IgG1 monoclonal antibody that binds to the p19 subunit of interleukin 23 (IL-23p19) and inhibits IL-23 signalling. The efficacy and safety of the new strength and presentation of Skyrizi was assessed in 2 studies in 265 adult patients with moderate to severe plaque psoriasis. Skyrizi demonstrated clinically meaningful improvement and was statistically superior to placebo with regard to the achievement of at least 90% reduction from baseline in the Psoriasis Area and Severity Index composite score and static Physician Global Assessment of clear or almost clear at Week 16 in adult patients with moderate to severe plaque psoriasis. The safety issues with Skyrizi treatment included infections and infestations and gastrointestinal disorders. The safety profile of risankizumab in this study was consistent with the already well-established safety profile of risankizumab in adults with moderate to severe plaque psoriasis. No new or unexpected safety findings were identified that would alter the overall safety profile of risankizumab.

This submission provides PK, safety and efficacy data supporting the use of a 150 mg/mL strength of Skyrizi PFS and 150 mg/mL strength of Skyrizi AI. The 150 mg/mL strength of Skyrizi allows for the administration of a 150 mg dose via a single 1 mL injection, rather than 2 separate 0.83 mL injections of 90 mg/mL.

The authorization of the new strength and presentation adds clinical value for healthcare professionals and patients, minimizing the number of injections required to achieve the 150 mg prescribed dose.

Overall, the benefit/risk profile of Skyrizi 150 mg/mL PFS/AI remain favourable in the target population of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.