AbbVie said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Skyrizi (Ingredient: risankizumab), an investigational interleukin-23 (IL-23) inhibitor for treating plaque psoriasis.
The committee gave the positive opinion based on the data from the global phase 3 clinical trial evaluating more than 2,000 adult patients with moderate to severe plaque psoriasis across four pivotal studies.
The studies all reached co-primary and ranked secondary endpoints, achieving a significantly higher response of clear or almost clear skin, Static Physicians Global Assessment 0/1 and Psoriasis Area and Severity Index of 90, compared to ustekinumab, adalimumab, and placebo at week 16 and up to week 52.
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients, while the 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," AbbVie Vice Chairman and President Michael Severino said. "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 and risk profile.”
At one year, more than 50 percent of patients receiving risankizumab achieved completely clear skin, he added.
Severino stressed that the positive opinion is an essential regulatory milestone in the company’s relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions.
The CHMP’s positive opinion is a scientific recommendation for marketing authorization to the European Commission, 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 will come within 67 days following the CHMP opinion.