ABBVIE INC — Skyrizi FDA Review (NDA/BLA 761105, 2022)

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The FDA approved AbbVie's Skyrizi (risankizumab-rzaa) 150 mg/mL formulation in pre-filled syringe and autoinjector presentations for moderate-to-severe plaque psoriasis. This approval followed review of sBLAs, pharmacokinetic comparability, efficacy, and safety studies. Clinical trials demonstrated Skyrizi's superiority over placebo in improving psoriasis symptoms, with a durable response. The 150 mg/mL formulation exhibited an acceptable safety profile, consistent with the 90 mg/mL version, with mostly mild-to-moderate adverse events. Human factors validation studies for the new devices identified potential use errors, leading to labeling and instructional revisions to ensure safe and effective patient use. The FDA also addressed device performance, biocompatibility, and anti-drug antibody detection during the review process.

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