The Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Skyrizi is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (IL-23) cytokine, a naturally occurring cytokine that is involved in inflammatory and immune responses, and inhibits its interaction with the IL-23 receptor.

The approval was based on data from 4 pivotal studies (ultIMMa-1, ultIMMa-2, IMMhance and IMMvent) in which the co-primary endpoints were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo. These studies compared treatment with risankizumab to other plaque psoriasis agents such as adalimumab and ustekinumab as well as placebo.

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Commenting on the clinical development program for Skyrizi, Kenneth B. Gordon, MD, a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin said, “Risankizumab demonstrated high levels of skin clearance that persisted through 1 year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”

Skyrizi will be supplied in 75mg/0.83mL single-dose prefilled syringes and is expected to be available in early May. Treatment is administered by subcutaneous injection under the guidance and supervision of a healthcare professional; patients may self-inject Skyrizi following training.

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This article originally appeared on MPR