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."
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
GSK's meningitis vaccine candidate accepted for FDA review
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
AbbVie announces interim evaluation of Atogepant Phase three, open-label 156-week extension study