Posted by Michael Wonder on 01 May 2018
AbbVie submits marketing authorisation application to the EMA for investigational treatment risankizumab for moderate to severe plaque psoriasis
1 May 2018 - Application supported by four pivotal Phase 3 trials evaluating more than 2,000 patients with moderate to severe plaque psoriasis.
AbbVie announced that it has submitted a marketing authorisation application to the European Medicines Agency for risankizumab, an investigational interleukin-23 inhibitor, being evaluated for the treatment of patients with moderate to severe plaque psoriasis.
The marketing authorization application is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies: ultIMMA-1, ultIMMa-2, IMMhance and IMMvent. Across all four studies, risankizumab met all co-primary and ranked secondary endpoints with no new safety signals across the Phase 3 program. Top-line results of these clinical studies were previously announced in October and December 2017. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.
