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AbbVie files for SKYRIZI subcutaneous induction in Crohn's | Grafa
A subcutaneous induction option for SKYRIZI could let people with Crohn’s start and continue treatment with injections instead of beginning with an IV infusion, which may affect convenience, time in clinic, and infusion planning.
Adults with moderately to severely active Crohn's disease, patients currently on or considering biologic therapy, clinicians who treat IBD, and researchers tracking drug approvals and administration options.
What To Know
AbbVie submitted an sBLA to the U.S. FDA requesting approval to use SKYRIZI (risankizumab-rzaa) as a fully subcutaneous induction therapy for adults with moderately to severely active Crohn's disease, based on positive Phase 3 AFFIRM data.
Currently SKYRIZI’s approved Crohn’s regimen begins with an IV induction followed by SC maintenance; the new request would allow an all‑SC option starting with induction. The article notes the proposed maintenance dose if patients respond to SC induction would be the established 360 mg every eight weeks.
This report focuses on a regulatory filing and potential change in the route of administration rather than new clinical details; it does not provide full study results or regulatory timelines. It frames the filing as part of AbbVie’s strategy to offer more convenient dosing choices in IBD care.
If the FDA approves the sBLA, some patients and clinicians could have the option to avoid IV induction infusions and start with subcutaneous injections instead, which may affect logistics and preferences for induction therapy.
Read the original source or AbbVie communications for full trial data and official regulatory updates before making any treatment decisions.
This is a regulatory submission based on Phase 3 AFFIRM study data; the article does not report full trial results or an FDA decision timeline. Approval is not guaranteed and would not immediately change prescribing until the FDA acts and labeling is updated.
