A 25-percentage-point gap in clinical remission at week 12 is the number driving AbbVie’s latest European regulatory move. In the Phase 3 AFFIRM study, 55% of adults with moderately to severely active Crohn’s disease receiving subcutaneous risankizumab induction achieved CDAI clinical remission versus 30% on placebo, with endoscopic response also meeting its co-primary endpoint. That data package now underpins a new submission to the European Medicines Agency seeking approval for SKYRIZI subcutaneous induction, an addition to the IV induction route the European Commission already cleared in November 2022.

The clinical logic is straightforward: risankizumab’s existing EU label covers 600 mg IV induction followed by 360 mg SC maintenance, meaning patients already transition to self-injectable dosing after induction. Adding a subcutaneous induction path removes the infusion requirement entirely for patients who can use it, a practically meaningful shift for both patients and the healthcare systems absorbing infusion center costs. AFFIRM enrolled 289 patients randomized 2:1, with 65% carrying a history of prior advanced therapy failure, a population where induction flexibility matters most because these patients often face high treatment burden from the start.

The competitive pressure behind this submission is real. Johnson and Johnson’s guselkumab received European Commission approval for Crohn’s disease as a dual-acting IL-23p19 inhibitor offering both IV and subcutaneous induction regimens, meaning the option to initiate treatment without an infusion is no longer a differentiator AbbVie can leave on the shelf. Retaining formulary position in European markets where payers scrutinize route-of-administration economics requires the full toolkit, not just the molecule. A label that forces IV induction when a competitor does not creates a friction point at initiation that compounds over time in a chronic disease.

The trial design included a 52-week open-label extension period, so durability data beyond the 12-week induction window will eventually accompany the regulatory dossier. The single number to track from here is EMA’s Day 70 list of outstanding issues, which will signal whether the agency sees the AFFIRM dataset as adequate on its own or whether it intends to scrutinize the SC-versus-IV comparability question before granting the label expansion.

Source link: https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-ema-for-skyrizi-risankizumab-subcutaneous-induction-for-adults-with-moderately-to-severely-active-crohns-disease-302861059.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.