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.
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.
For more information visit skyrizihcp.com.