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AbbVie has announced that the US FDA has granted the approval of Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe plaque psoriasis.
Skyrizi is an interleukin-23 (IL-23) inhibitor that was also recently approved in Canada and Japan. Skyrizi is the third IL-23 inhibitor (behind guselkumab [Tremfya] and tildrakizumab [Ilumya]) to be approved in the last year.
US approval is based on four large phase 3 pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. These trials demonstrated 75% PASI 90 scores after 16 weeks of therapy. After 1 year of Skyrizi therapy, over 80% of psoriasis patients achieves a PASI 90 and over half achieve completely clear skin (PASI 100).
Skyrizi is given as two subcutaneous injections ((75 mg. each or 150mg total) initially, and at week 4 and thereafter every 12 weeks.
The most common adverse events were upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection site reactions (1.5%) and tinea infections (1.1%). The drug also requires an initial evaluation for tuberculosis (TB) prior to starting therapy.
Abbvie projects Skyrizi to be commercially available in the U.S. in early May 2019.