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AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Moderate to Severe Active Crohn’s Disease

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AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Moderate to Severe Active Crohn's Disease | PTF

AbbVie announced the European Commission (EC) has approved SKYRIZI (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn’s disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

“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,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “The approval of SKYRIZI in the European Union is a significant milestone in our pursuit to expand our IBD portfolio.”

The EC approval for SKYRIZI in Crohn’s disease is supported by results from the global Phase 3 program, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance. The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies and include assessments of efficacy, safety and tolerability of SKYRIZI.

Clinical Remission & Endoscopic Response

  •  In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response.
    • In ADVANCE and MOTIVATE, 43% and 35% of patients treated with SKYRIZI 600 mg IV achieved clinical remission at week 12, respectively, compared to 22% and 19% of patients receiving placebo.
    • Additionally, 40% and 29% of SKYRIZI treated patients achieved endoscopic response at week 12 compared to 12% and 11% of patients receiving placebo.
  • In the FORTIFY maintenance trial, a significantly greater proportion of patients treated with SKYRIZI 360 mg SC achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response.
    • In FORTIFY, 52% of patients treated with SKYRIZI 360 mg SC achieved clinical remission at week 52 compared to 40% of patients receiving placebo.
    • Additionally, 47% of patients treated with SKYRIZI achieved endoscopic response at week 52 compared to 22% of patients receiving placebo.

Mucosal Healing & Endoscopic Remission

  • During the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved mucosal healing and endoscopic remission.
    • In ADVANCE and MOTIVATE, 21% and 14% of patients treated with SKYRIZI 600 mg IV achieved mucosal healing at week 12, respectively, compared to 8% and 4% of patients receiving placebo.
    • Additionally, during the induction studies, 24% and 19% of patients treated with SKYRIZI 600 mg IV achieved endoscopic remission at week 12, respectively, compared to 9% and 4% of patients receiving placebo.
  • Mucosal healing and endoscopic remission were observed during the FORTIFY maintenance trial in patients treated with SKYRIZI 360 mg SC.
    • In FORTIFY, mucosal healing was observed at week 52 in 31% of patients treated with SKYRIZI 360 mg SC compared to 10% of patients receiving placebo (nominal p-value<0.001).
    • Additionally, endoscopic remission was observed at week 52 in 39% of patients treated with SKYRIZI 360 mg SC compared to 13% of patients receiving placebo (nominal p-value<0.001).

“Beyond managing daily symptoms, clinical remission and endoscopic goals are key treatment targets in Crohn’s disease,” said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. “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.”

Additionally, across all three studies, safety results of SKYRIZI in Crohn’s disease were consistent with the known safety profile of SKYRIZI, with no new safety risks observed. In ADVANCE, the most common adverse events (AEs) observed in the SKYRIZI treatment groups were headache, nasopharyngitis and fatigue. In MOTIVATE, the most common AEs observed were headache, arthralgia and nasopharyngitis. In FORTIFY, the most common AEs were exacerbation of Crohn’s disease, nasopharyngitis and arthralgia.

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