Shots:
- The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn’s disease (CD)
- Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded or open-label Period B (Wk. 12 to 24) based on clinical response at Wk. 12, & a 52wk. OLE Period C
- Skyrizi is an IL-23 inhibitor that selectively targets the p19 subunit to block IL-23, & is approved in the US & EU for plaque psoriasis, psoriatic arthritis, CD and ulcerative colitis
Ref: PRnewswire | Image: AbbVie | Press Release
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