AbbVie has announced the US Food and Drug Administration (FDA) approval of its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis.
The indication is for adults who are candidates for systemic therapy or phototherapy, based on a Phase III trial in which the drug produced high rates of durable skin clearance.
Most people (82 and 81%) treated with SKYRIZI achieved 90% skin clearance (PASI 90) at one year, with the majority (56 and 60%) achieving complete skin clearance (PASI 100).
Skyrizi, which is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally, is also currently under evaluation in Europe for a marketing authorisation application (MAA) from the European Medicines Agency (EMA), for the treatment of patients with moderate to severe plaque psoriasis.
"The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth Gordon, a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin.
He continued, "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one 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."
Psoriasis is the most prevalent autoimmune disease in the U.S, characterised by over activation of the immune system and widespread inflammation that causes painful, itchy plaques anywhere on the skin.