ABBV 066 filed with EU for moderate to severe plaque psoriasis.- AbbVie.

AbbVie has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for ABBV 066 (risankizumab), an investigational interleukin-23 (IL-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 III psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase III 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 III 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.

Comment: ABBV 066 was filed with the FDA for moderate to severe plaque psoriasis at the end of April 2018.