Policy & Regulation
AbbVie receives approval from European Commission Approval for Crohn's Disease treatment SKYRIZI (risankizumab)
23 November 2022 -

Biopharmaceutical company AbbVie (NYSE: ABBV) disclosed on Wednesday that the European Commission (EC) has approved SKYRIZI (risankizumab, 600mg intravenous [IV] induction and 360mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

The company said that Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhoea, abdominal pain and can require urgent medical care.

AbbVie also stated that the EC approval for SKYRIZI in Crohn's disease is supported by results from the global Phase 3 programme, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance. These multicentre, randomised, double-blind, placebo-controlled Phase 3 studies include assessments of efficacy, safety and tolerability of SKYRIZI.

Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie, commented: "There are still many patients suffering from debilitating symptoms associated with Crohn's disease, such as abdominal pain and stool frequency, which is why we've embraced the challenge of serving these patients in need." He added: "The approval of SKYRIZI in the European Union is a significant milestone in our pursuit to expand our IBD portfolio."

Login
Username:

Password:


Related Headlines