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

AbbVie has filed ABBV 066 (risankizumab) with the FDA, seeking approval for its use to treat moderate-to-severe plaque psoriasis. The submission was supported by four Phase III studies involving more than 2,000 patients, which showed more than half of patients receiving the drug achieved complete skin clearance (PASI 100) at one year.

In the pivotal Phase III ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab 150 mg compared to placebo or ustekinumab 45 or 90 mg in adult patients with moderate to severe chronic plaque psoriasis, results at week 16 and one year (52 weeks) demonstrated significantly higher rates of clear skin (sPGA 0), both ranked secondary endpoints, in patients treated with risankizumab, compared to ustekinumab patients in ultIMMa-1 and ultIMMa-2 (58% and 60% vs 21% and 30% respectively). The first phase of IMMhance, the fourth pivotal Phase III trial, showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) versus placebo. In the second phase of this study, the primary endpoint of sPGA 0/1 at week 52 (one year) was also met.