For CD patients, Skyrizi will be supplied in a 600mg/10mL single-dose vial for IV infusion during the induction period (for administration by a health care provider) and a 360mg/2.4mL single-dose ...

(RTTNews) - AbbVie (ABBV) presented positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of risankizumab (Skyrizi, 600 mg intravenous [IV] at week 0 ...

Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis ... Endoscopic response was achieved in 40% and 32% of patients for the 600mg and 1200mg doses, respectively, versus 12% ...

Additionally, during the induction studies, 24% and 19% of patients treated with Skyrizi 600 mg IV achieved endoscopic remission at week 12, respectively, compared to 9% and 4% of patients receiving ...

Skyrizi’s latest approval is based on the results of two pivotal studies that compared the AbbVie drug to a placebo. The drug was dosed as a hour-long 600 mg infusion at the start of the study ...

The regulatory filing seeks approval for Skyrizi both as a 600mg intravenous (“IV”) induction and 360mg subcutaneous (“SC”) maintenance therapy in patients aged 16 years and older with CD.

Endoscopic response was shown in 11.2% of placebo recipients vs. 28.8% of the 600 mg group and 34.2% of the 1,200 mg group. “There is clearly no dose-dependent effect,” D’Haens said.

Patients received 600 mg or 1200 mg, of Skyrizi (risankizumab, AbbVie) or placebo at weeks 0, 4 and 8 and those that received the treatment drug showed greater rates of remission.

Data from two phase III induction studies — ADVANCE and MOTIVATE — evaluating two doses of Skyrizi (600mg & 12mg) showed that significantly more patients treated with risankizumab achieved ...

AbbVie, Inc. ABBV announced that it submitted a regulatory application with the European Medicines Agency (EMA), seeking approval for its interleukin-23 (“IL-23”) inhibitor risankizumab ...