United States-based AbbVie (NYSE: ABBV) announced on Monday that it has submitted an application to the United States Food and Drug Administration (FDA) requiring approval for risankizumab-rzaa (600mg intravenous (IV) induction and 360mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor to treat patients 16 years and older with moderate to severe Crohn's disease.
The submission is based on the safety and efficacy data from three Phase three studies, ADVANCE, MOTIVATE and FORTIFY. The safety profile of all tested doses of the product in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies was consistent with the safety profile of risankizumab-rzaa.
The ADVANCE and MOTIVATE studies are Phase three multicentre, randomised, double-blind, placebo-controlled induction studies aimed at assessing the efficacy and safety of two doses of risankizumab-rzaa, 600mg and 1200mg, in adults with moderate to severe Crohn's disease, compared to placebo.
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