Friday’s European Commission approval is a boost to AbbVie as the company looks to lean on its immunology assets, including Skyrizi, to soften the blow of Humira’s loss of exclusivity.
The European Commission on Friday approved the use of AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active ulcerative colitis.
Skyrizi can now be used for this indication in the European Union, though is limited to patients who have had inadequate response to prior conventional or biologic therapies. The antibody therapy can also be used for patients who have lost response to, or are otherwise intolerant to, conventional or biologic treatments. Skyrizi also recently won the FDA’s approval for ulcerative colitis.
AbbVie CSO Roopal Thakkar said in a statement that Skyrizi’s ulcerative colitis approval in the European Union “provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use.”
The European Commission’s decision was backed by data from the Phase III INSPIRE and COMMAND clinical trials, which showed that Skyrizi treatment resulted in high remission rates. In the induction study INSPIRE, 20% of patients treated with intravenous Skyrizi hit clinical remission at 12 weeks—as determined by the Adapted Mayo Score—versus 6% in the placebo group.
In COMMAND, the 180-mg and 360-mg subcutaneous doses of Skyrizi elicited 40% and 38% remission rates at 52 weeks, respectively, compared to only 25% in counterparts who received induction only. Both studies showed that Skyrizi could trigger significant mucosal healing and histologic endoscopic mucosal healing, compared with placebo.
Skyrizi is a humanized IgG1 monoclonal antibody that works by targeting the inflammatory IL-23 cytokine, blocking its interaction with its corresponding receptor. By disabling this signaling cascade, Skyrizi can dampen the inflammation process and addressing the underlying pathway of several immune-mediated diseases.
In addition to ulcerative colitis, Skyrizi is also approved for plaque psoriasis, psoriatic arthritis and Crohn’s disease in the European Union. In the U.S., Skyrizi is currently indicated for ulcerative colitis, plaque psoriasis, Crohn’s disease and psoriatic arthritis, according to its label.
Skyrizi’s European nod comes as AbbVie tries to bolster its portfolio to weather the ongoing patent cliff for Humira (adalimumab). In its second-quarter 2024 business report last week, the pharma announced that sales of the blockbuster drug dropped by almost 30%. However, AbbVie’s overall revenue still beat analysts’ expectations.
In Q2, Skyrizi grew almost 45% year-over-year to $2.7 billion. Rinvoq, which is approved for rheumatoid arthritis and ulcerative colitis, surged 55.8% to hit $1.4 billion in sales in the quarter.
Correction (July 30): This story has been updated to clarify that the FDA has approved Skyrizi for ulcerative colitis in June 2024. A previous misspelling of Skyrizi was also corrected. BioSpace regrets the errors.
