By: IPP Bureau
Last updated : June 01, 2024 3:53 pm
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
AbbVie announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI) for the treatment of 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 recommended induction dose is 1200 mg intravenous (IV), followed by a maintenance dose of 180 mg or 360 mg subcutaneous (SC), based on individual patient presentation. The final European Commission decision is expected in the third quarter of 2024.
"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," said Edouard Louis, M.D., Ph.D., professor and head of gastroenterology, Liège University Hospital; dean of faculty, Liège University; and INSPIRE trial investigator. "This finding is significant since treatment goals for patients are evolving beyond symptom management to include endoscopic remission.7-9 Studies have shown that endoscopic improvement may be associated with favorable longer-term outcomes, including lower risk of hospitalizations and improved quality of life."
The CHMP positive opinion is supported by data from two Phase 3 clinical trials.
"At AbbVie, patients are at the heart of everything we do," said Kori Wallace, M.D., Ph.D., vice president, immunology clinical development, AbbVie. "We are motivated to bring new treatment options to patients in need through our commitment to ongoing research and development in gastroenterology. We eagerly await the EMA's final decision for risankizumab on its use in UC which has the potential to help patients meet their long-term treatment goals."
Use of risankizumab in UC is not approved in the European Union, and its safety and efficacy remain under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.