AbbVie announced Wednesday the submission of an application to the FDA seeking approval of risankizumab for the treatment of patients with moderate-to-severe plaque psoriasis. The investigational IL-23 inhibitor is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialisation globally.
AbbVie chief scientific officer Michael Severino commented "the risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases," continuing "risankizumab has the potential to be an important treatment option for people living with plaque psoriasis and we look forward to working with the FDA throughout the review process."
AbbVie noted that the filing was supported by safety and efficacy data from a clinical programme involving more than 2000 patients from four late-stage trials. In study data unveiled in February, risankizumab was associated with significantly higher rates of skin clearance at week 16 and at one year of treatment compared to Johnson & Johnson's Stelara (ustekinumab).
AbbVie stated that late-stage trials of risankizumab are ongoing for the treatment of Crohn's disease and psoriasis, while it is also being investigated to treat psoriatic arthritis. The drugmaker added that studies of the IL-23 inhibitor in patients with ulcerative colitis have been planned. The drug was previously granted orphan drug status by the FDA for the treatment of children with Crohn's disease.
Separately on Wednesday, AbbVie reported that in a Phase IIb/III study of adult Japanese patients with moderate-to-severe rheumatoid arthritis, all doses of upadacitinib met the study's primary endpoint of ACR20 versus placebo. The company noted that the experimental oral JAK1-selective inhibitor also achieved certain key efficacy goals versus placebo in the SELECT-SUNRISE trial.
In the study, Japanese adults with moderate-to-severe rheumatoid who had an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) were randomly assigned to treatment with upadacitinib, at a dose of 7.5 mg, 15 mg or 30 mg, or placebo. The primary endpoint of the study was the proportion of patients with an ACR20 response at week 12, while key secondary endpoints included the proportions of patients with ACR50, ACR70, clinical remission and low disease activity at week 12.
According to AbbVie, results from the study illustrated that the ACR rates in the 7.5-mg, 15-mg and 30-mg dose groups were 76 percent, 84 percent and 80 percent, respectively, versus 43 percent for placebo. Meanwhile, 41 percent, 65 percent and 58 percent of patients in the low-, medium- and high-dose groups achieved ACR50 responses, compared with 16 percent of patients in the placebo group.
Additionally, the drugmaker noted that significantly higher rates of clinical remission and disease activity at week 12 were achieved in the upadacitinib groups versus placebo. Severino remarked "we are encouraged by these data, which show that upadacitinib provides improvements in important measures…in people living with rheumatoid arthritis in Japan."
FirstWord reports in this therapy area - KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
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