Skyrizi is a humanised monoclonal antibody inhibitor that selectively targets interleukin-23 (IL-23), a cytokine involved in inflammatory processes, and was previously approved in the EU to treat moderate to severe plaque psoriasis
AbbVie has received the European Commission (EC) approval for Skyrizi (risankizumab) to treat moderate to severe Crohn’s disease in adults.
Skyrizi is a humanised monoclonal antibody inhibitor that selectively blocks interleukin-23 (IL-23), a cytokine involved in inflammatory processes, by binding to its p19 subunit.
The drug is being developed under collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation worldwide.
It was previously approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are eligible for receiving systemic therapy.
The EC approval expands the drug’s indication to include adults with active Crohn’s disease, who are not responding or intolerant to conventional or biological therapy.
Skyrizi is recommended for use as a 600mg intravenous (IV) induction and 360mg subcutaneous (SC) maintenance therapy.
Currently, Skyrizi is being evaluated in ongoing Phase 3 trials in treating psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
AbbVie chief scientific officer, research and development senior vice president Thomas Hudson said: “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.
“The approval of Skyrizi in the European Union is a significant milestone in our pursuit to expand our IBD portfolio.”
The EC approval is supported by results from the global Phase 3 programme that comprised ADVANCE induction, MOTIVATE induction and FORTIFY maintenance trials.
All three Phase 3 trials are multicentre, randomised, double-blind, placebo-controlled studies that evaluated the efficacy, safety, and tolerability of Skyrizi.
In the ADVANCE and MOTIVATE induction trials, patients treated with Skyrizi 600mg IV achieved the co-primary endpoints of clinical remission and endoscopic response.
In the FORTIFY maintenance trial, patients treated with Skyrizi 360mg SC achieved the co-primary endpoints of clinical remission and endoscopic response.
University Hospitals Leuven department of gastroenterology and hepatology associate professor Marc Ferrante said: “Beyond managing daily symptoms, clinical remission and endoscopic goals are key treatment targets in Crohn’s disease.
“Research advancements have made it possible for patients to aim for higher treatment goals, including mucosal healing.
“The approval of Skyrizi as the first IL-23 inhibitor for moderate to severe Crohn’s disease is a critical step forward towards a treatment option that can support a patient’s health goals.”