AbbVie Inc. (ABBV) announced Friday that Friday that Risankizumab (SKYRIZI) has been recommended for European Union approval for the treatment of adults with moderately to severely active Ulcerative Colitis or UC.
The European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending the approval of risankizumab (SKYRIZI) to treat adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy.
The company noted that the recommended induction dose is 1200 mg intravenous or IV, followed by a maintenance dose of 180 mg or 360 mg subcutaneous or SC, based on individual patient presentation.
The final European Commission decision is expected in the third quarter of 2024.
UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease or IBD affecting the large intestine. It can lead to a substantial burden and often results in disability.
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
The CHMP's positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in adults with moderately to severely active UC.
In both trials, the primary endpoint of clinical remission and key secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement, were met.
Edouard Louis, INSPIRE trial investigator, said, "Results from the INSPIRE and COMMAND Phase 3 trials show that patients with moderately to severely active UC can strive for long-term management goals that go beyond symptom control, including histologic-endoscopic mucosal healing. This finding is significant since treatment goals for patients are evolving beyond symptom management to include endoscopic remission."
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