05:23 AM EDT, 07/26/2024 (MT Newswires) -- AbbVie ( ABBV ) said Friday the European Commission has approved Skyrizi for treating adult patients with moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease.
The marketing authorization for Skyrizi marks its fourth approved indication in the European Union, the company said.
The medication is for patients who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapy.
AbbVie ( ABBV ) said data from two phase 3 trials supported the authorization. Skyrizi achieved the primary endpoint of clinical remission and main secondary endpoints, including mucosal, healing in both trials.