By SPC News Staff
The FDA granted a new indication for risankizumab-rzaa (Skyrizi, AbbVie) to treat adults with active psoriatic arthritis (PsA).
The FDA indication is supported by data from two pivotal phase 3, multicenter, randomized, double-blind, placebo-controlled studies—KEEPsAKE-1 and KEEPsAKE-2 (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148)—which evaluated the efficacy and safety of risankizumab-rzaa in adults with active PsA, including those who had responded inadequately