Officials with the FDA have approved risankizumab-rzaa (Skyrizi, AbbVie) for the treatment of moderate-to-severe plaque psoriasis, according to a press release. The treatment is indicated for adults who are candidates for systemic therapy or phototherapy.
The recommended dose of risankizumab-rzaa is 150 mg, administered by 2 subcutaneous injections every 12 weeks following 2 initiation doses at weeks 0 and 4, according to AbbVie. The treatment can be administered in-office or by self-injection after training.
Risankizumab-rzaa, an interleukin-23 (IL-23) inhibitor, selectively blocks IL-23 by binding to its p19 subunit. IL-23 is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis, which is the most prevalent autoimmune disease in the United States.
This approval is based on data from AbbVie’s phase 3 psoriasis clinical trial program, which evaluated the safety and efficacy of risankizumab-rzaa in adults with moderate-to-severe plaque psoriasis across 4 studies: ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent. According to the study, patients treated with risankizumab-rzaa every 12 weeks achieved high levels of durable skin clearance at 16 weeks and maintained this response at 1 year.