AbbVie’s Skyrizi gains fourth EU approval for ulcerative colitis

AbbVie’s Skyrizi (risankizumab) has recently been granted its fourth approved indication in Europe. On Friday, it received clearance for treating adults with moderately-to-severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapies. Skyrizi is an IL-23 inhibitor developed in collaboration with Boehringer Ingelheim. Previously, it had been approved in the EU for plaque psoriasis, psoriatic arthritis, and Crohn's disease. Additionally, it received authorization from the FDA for UC treatment last month.

The new European approval is underpinned by the results of the Phase III INSPIRE induction trial and the COMMAND maintenance study. Both studies achieved their primary objective of clinical remission and also met the secondary endpoint of endoscopic improvement. According to Roopal Thakkar, AbbVie’s chief scientific officer, "Notably, we observed positive results in mucosal healing particularly in patients without previous biologic experience or JAK inhibitor failure."

AbbVie detailed Skyrizi’s dosing regimen for this indication, which involves a 12-week induction period with three 1200-mg intravenous doses administered every four weeks. This induction phase is followed by a maintenance regimen of either 180 mg or 360 mg every eight weeks. Maintenance dosing can be conveniently done at home using an on-body injector.

Financially, Skyrizi has shown robust performance, generating $2.7 billion in sales in the second quarter, a 45% increase compared to the previous year. AbbVie’s CEO Robert Michael mentioned that Skyrizi continues to gain momentum in the treatment of psoriasis and Crohn's disease. He also pointed out that there is considerable potential for further market share expansion, with UC representing another avenue for sustained growth.

In summary, Skyrizi’s new European approval for the treatment of moderately-to-severely active ulcerative colitis marks its fourth indication in the region. Supported by positive Phase III trial results, the drug's latest approval enhances its growing profile and market potential. The strategic dosing regimen and strong financial performance underline Skyrizi’s role in AbbVie's long-term growth strategy.