European Commission Approves Risankizumab for Plaque Psoriasis

Megan Brooks

Disclosures

May 01, 2019

The European Commission (EC) has approved risankizumab (Skyrizi, AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

The action comes 2 months after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the drug, as reported by Medscape Medical News.

Rizankizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23. It is given in two subcutaneous injections of 75 mg each every 12 weeks following two initiation doses at week 0 and week 4.

The approval was based on results from four phase 3 studies that involved more than 2000 patients with moderate to severe plaque psoriasis.

In all four studies, all coprimary and ranked secondary endpoints were met. There was a significantly higher response to risankizumab, in which patients experienced 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), according to AbbVie.

"In clinical studies, patients saw significantly higher rates of skin clearance with Skyrizi compared to current standards of care," Hervé Bachelez, PhD, of the Saint-Louis Hospital in Paris, France, who was principal investigator of one of the studies, said in a company news release. "As many as 80% of patients who achieved clear skin at 16 weeks maintained completely clear skin through one year."

The company plans to present 2-year data from one of the studies next month at the World Congress of Dermatology in Milan, Italy.

The most common adverse reactions were upper respiratory infections, which occurred in 13% of patients. Most of the reported adverse reactions were of mild or moderate severity.

"This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option [that] has the potential to provide long-term relief from the signs and symptoms of psoriasis," AbbVie vice chairman and president Michael Severino, MD, said in the release.

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