**AbbVie Inc. Announces EU Recommendation for SKYRIZI in Treating Ulcerative Colitis**
AbbVie Inc. (ABBV) stated on Friday that Risankizumab (SKYRIZI) has garnered a recommendation for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to treat adults with moderately to severely active Ulcerative Colitis (UC).
CHMP has issued a positive opinion suggesting the approval of SKYRIZI for adults with moderately to severely active UC who have either had an inadequate response, lost response, or were intolerant to conventional or biologic therapies.
The advised induction dosage is 1200 mg administered intravenously (IV), followed by a maintenance dose of either 180 mg or 360 mg subcutaneously (SC), depending on individual patient needs.
The European Commission's final decision on this recommendation is anticipated in Q3 2024.
UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) that affects the large intestine. It imposes a considerable burden on patients, often leading to disability.
Risankizumab, developed collaboratively by Boehringer Ingelheim and AbbVie, with AbbVie spearheading its development and global commercialization, has shown promising results.
The CHMP's recommendation is rooted in the outcomes of two pivotal Phase 3 trials, INSPIRE and COMMAND. These trials assessed the efficacy and safety of SKYRIZI in adults with moderately to severely active UC.
Both trials successfully met their primary endpoint of clinical remission, alongside key secondary endpoints such as endoscopic improvement and histologic-endoscopic mucosal improvement.
Edouard Louis, an investigator for the INSPIRE trial, highlighted, "Results from the INSPIRE and COMMAND Phase 3 trials indicate that patients with moderately to severely active UC can aspire to long-term management goals beyond symptom control, including histologic-endoscopic mucosal healing. This finding is significant as treatment objectives are evolving beyond mere symptom management to achieving endoscopic remission."
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