AbbVie has formally asked the U.S. Food and Drug Administration to authorize a subcutaneous induction dosing regimen for SKYRIZI (risankizumab-rzaa) to treat adults with moderately to severely active Crohn’s disease, the company said.
The submission rests on data from the Phase 3 AFFIRM study, which assessed the safety and efficacy of subcutaneously administered risankizumab as an induction therapy in 289 adult patients with the disease. In the trial, participants were randomized in a 2:1 ratio to receive subcutaneous risankizumab or placebo. A notable feature of the trial population is that 65% of enrolled patients had previously not responded to advanced therapies for Crohn’s disease.
SKYRIZI was the first interleukin-23 specific inhibitor to receive FDA approval for adults with moderately to severely active Crohn’s disease in 2022. At present, induction dosing for the drug is delivered via intravenous infusion. The new regulatory request, if granted, would add a subcutaneous induction option, giving patients and clinicians the choice between an injection-based induction or the existing IV infusion approach. After induction, the proposed regimen calls for subcutaneous maintenance dosing every eight weeks.
The AFFIRM study designated two co-primary endpoints to measure treatment effect: the achievement of CDAI Clinical Remission and an endoscopic response at week 12. AbbVie indicated it expects a regulatory decision on the filing later this year.
Crohn’s disease affects approximately 1 million Americans and is marked by chronic inflammation in the gastrointestinal tract, most commonly between the small intestine and the colon. Symptoms include persistent diarrhea and abdominal pain, and the condition is progressive - in some cases it results in complications that require surgical intervention.
SKYRIZI already holds regulatory approvals from both the U.S. Food and Drug Administration and the European Medicines Agency for multiple indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Context and next steps
The company’s regulatory filing follows completion of the Phase 3 AFFIRM trial and is now under review by the FDA. The agency’s decision on permitting a subcutaneous induction option for SKYRIZI is expected later in the year, according to AbbVie.