New IL23 inhibitor to treat psoriasis closer to approval

AbbVie has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Skyrizi (risankizumab), an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

The CHMP positive opinion is supported by data from the global Phase III psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase III studies. Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, all co-primary and ranked secondary endpoints were met, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90) compared to ustekinumab, adalimumab and placebo at week 16 and up to week 52 (depending on study design).

1-3 The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. 5 Most reported adverse reactions were mild or moderate in severity.