Posted by Michael Wonder on 02 Mar 2019
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of moderate to severe plaque psoriasis
1 March 2019 - CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission.
AbbVie today announced that the EMA CHMP adopted a positive opinion for Skyrizi (risankizumab), an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, 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, adalimumab and placebo at week 16 and up to week 52 (depending on study design).
