Posted by Michael Wonder on 25 Apr 2018
AbbVie submits biologics license application to U.S. FDA for investigational treatment risankizumab for moderate to severe plaque psoriasis
25 April 2018 - The biologics license application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis.
AbbVie announced that it has submitted a biologics license application to the U.S. FDA for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis.
The global risankizumab Phase 3 psoriasis program evaluates more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal studies. The studies include assessments of efficacy, safety and tolerability of risankizumab. Key measures of efficacy include measures of disease activity and skin clearance, including PASI 90, PASI 100 and sPGA 0/1, as well as long-term clinical outcomes.
