SKYRIZI Receives FDA Approval for Subcutaneous Induction Treatment in Adults with Crohn’s Disease – AbbVie

AbbVie announced the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn’s disease (CD).
Patients now have the option to start Skyrizi treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment.

“People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start. With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn’s disease.” – Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

Subcutaneous Skyrizi Shows High Rates of Clinical Remission and Endoscopic Response by Week 12

This FDA approval is supported by positive results from the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC Skyrizi versus placebo in patients with moderately to severely active CD. Skyrizi achieved superiority of the co-primary endpoints of clinical remission and endoscopic response at week 12. Although the study enrolled a primarily treatment-refractory population, these Phase 3 results were particularly strong within patients without prior advanced therapy failure (advanced therapy-naïve). By week 12, nearly three-quarters (74%) of advanced therapy (AT)-naïve patients were in clinical remission (vs. 27% placebo) and these AT-naïve patients achieved endoscopic response at four times the rate of placebo (60% vs. 15%, respectively). SC Skyrizi also had a higher efficacy response in patients who had previously failed advanced therapy.

SC Skyrizi also met secondary endpoints including endoscopic remission and FACIT fatigue scores at week 12 vs. placebo. The safety profile of SC Skyrizi for induction was generally consistent with its known profile in CD, with no new safety risks observed.

Together, these results demonstrate market-leading clinical and endoscopic outcomes in advanced therapy-naïve patients that set a high bar in CD. Furthermore, the strength of these subcutaneous results provides a compelling foundation for future clinical trials.