The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
The FDA on Oct. 23 approved a subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease, extending the company's on-body injector (OBI) from maintenance into the first weeks of treatment.1
The approval changes the delivery route and device use for an established antibody rather than adding a new indication; intravenous induction remains available.1 AbbVie submitted the application April 27, as
Lead investigator Millie D. Long, M.D., of the University of North Carolina at Chapel Hill, said: "When patients and I discuss treatment, they want to know two things: will it work? And how will it fit into their lives? AFFIRM answered the first question, with superior rates of clinical remission and endoscopic response versus placebo during induction with subcutaneous Skyrizi, particularly in patients new to advanced therapy. This approval answers the second. As a physician who has used the Skyrizi OBI, I've seen firsthand the convenience it can offer patients. Now with this approval, patients can start treatment at home and continue the same way through maintenance."
The subcutaneous regimen is 720 mg delivered by an OBI induction pack at weeks 0, 2, 4 and 8, while the intravenous option remains 600 mg at weeks 0, 4 and 8.1 Maintenance begins at week 12 with OBI dosing every eight weeks, and the device was first introduced in 2022 for Crohn's disease maintenance.1
The label lists the injector with 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridges, alongside a 600 mg/10 mL intravenous vial.1 The release does not explain how the 720 mg induction dose is assembled from those presentations, and it gives no manufacturing or supply details.
AbbVie cited two surveys: 88% of 186 people with Crohn's disease found the injector easy to use, and 87% of 352 adults with inflammatory bowel disease were satisfied or highly satisfied with it versus 71% for an autoinjector.1 The autoinjector comparison is listed as company data on file, so it cannot be independently assessed.
Risankizumab is a monoclonal antibody that binds the p19 subunit of interleukin-23, a cytokine involved in inflammatory processes and thought to be linked to several chronic immune-mediated diseases.1,3 Skyrizi is also approved in the United States for ulcerative colitis, plaque psoriasis and psoriatic arthritis.1
In the earlier phase 3 trials of intravenous induction, week 12 clinical remission occurred in 45% of patients receiving 600 mg versus 25% with placebo in ADVANCE, and 42% versus 20% in MOTIVATE.3 Those trials enrolled different populations, so the figures are not directly comparable with AFFIRM.
AFFIRM randomized 274 adults 2:1 to subcutaneous risankizumab or placebo, and 65% had previously failed advanced therapy.1 The co-primary endpoints at week 12 were clinical remission, defined as a Crohn's disease activity index score below 150, which occurred in 56% of treated patients versus 30% with placebo, and endoscopic response, 43% versus 15% (both p<0.001).1
Endoscopic remission, a secondary endpoint, was 26% versus 11%.1 Rates were higher in patients without prior advanced therapy failure (74% versus 27% and 60% versus 15%) than in those with prior failure (45% versus 31% and 33% versus 15%).1
AbbVie reported no new safety risks.1
Roopal Thakkar, M.D., AbbVie's executive vice president, research and development, and chief scientific officer, said: "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."
The April filing sought approval of a new dosing regimen for an already-approved product.2 FDA also approved revised prescribing information across all indications, advising clinicians to consider tuberculosis evaluation based on clinical judgment; no test is mandatory before treatment.1 Liver monitoring language for Crohn's disease remains in the label.1
The advanced therapy-naive subgroup was small, with 65 treated and 33 placebo patients, and the reported p-values apply to the total population rather than subgroups.1 Results from AFFIRM's extension periods were not reported, and the safety conclusion rests on the sponsor's summary.1
Sources
