EU Panel Backs Risankizumab (Skyrizi) for Plaque Psoriasis

Megan Brooks

March 01, 2019

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for approval interleukin-23 (IL-23) inhibitor risankizumab (Skyrizi, AbbVie) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Risankizumab was tested in more than 2000 patients with moderate to severe plaque psoriasis across four phase 3 studies. The studies assessed efficacy and safety of risankizumab at 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.

Across all four studies, 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 (Stelara, Janssen), adalimumab (Humira, AbbVie), and placebo at week 16 and up to week 52 (depending on study design), AbbVie said in a news release.

The most common adverse reactions were upper respiratory infections, which occurred in 13% 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," Michael Severino, MD, AbbVie vice chairman and president, said in the release.

"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% of patients receiving risankizumab achieved completely clear skin," Severino added. 

Detailed recommendations for the use of risankizumab will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

Risankizumab should be prescribed by physicians experienced in the treatment of psoriasis, the EMA said.

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