CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission.
AbbVie, a research-based global biopharmaceutical company, today 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 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 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). The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Most reported adverse reactions were mild or moderate in severity.
“Plaque psoriasis can have a significant physical, psychological and social burden on people living with the condition,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We are excited that the CHMP has recognized risankizumab’s potential to significantly reduce the signs and symptoms of psoriasis and provide an improved quality of life. In clinical studies, risankizumab demonstrated consistently high rates of skin clearance with a favorable benefit/risk profile. At one year, more than 50 percent of patients receiving risankizumab achieved completely clear skin. This is an important regulatory milestone in our relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions.”
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision, valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. The Commission decision is anticipated within 67 days following the CHMP opinion.