The U.S. Food and Drug Administration approved Skyrizi (Ingredient: risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, which treats moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, AbbVie Korea said Thursday.

Psoriasis is the most prevalent autoimmune disease. The disease excessively activates the immune system and causes extensive inflammation, which can result in painful, scarlet, plate-like lesions on the skin.

Also, patients with psoriasis go through severe emotional, psychological and social burdens, which can negatively impact their quality of life.

The FDA approved the treatment based on the results from AbbVie's global phase 3 psoriasis trial, which assessed the safety and efficacy of the treatment in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies --ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent.

The co-primary endpoints of these studies 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.

In clinical trials, the treatment produced high rates of durable skin clearance with most 82 percent of patients in the ultIMMa-1 study and 81 percent of patients in the ultIMMa-2 study treated with Skyrizi achieving 90 percent skin clearance (PASI 90) during the first year of treatment. Also, 56 percent of patients in the ultIMMa-1 study and 60 percent of the patients in the ultIMMa-2 study achieved complete skin clearance (PASI 100).

"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 Professor Kenneth B. Gordon., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased that the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

The recommended dose for Skyrizi is 150mg – administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and 4. Patients can either receive the injection at hospitals or self-inject the drug after training.

"The approval of Skyrizi is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time," AbbVie Vice Chairman and President Michael Severino said.

He went on to say, “Skyrizi builds on AbbVie's legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions."