European Authority Backs AbbVie's Crohn's Disease Candidate

  • The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of AbbVie Inc's ABBV risankizumab regime for Crohn's disease.
  • The recommendation comes for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) for active Crohn's disease who have had an inadequate response, lost response, or was intolerant to conventional or biologic therapy.
  • Related: AbbVie Psoriatic Arthritis Drug Shows Long-term Effect On Skin, Joint Symptoms.
  • Three Phase 3 trial data support the backing. Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission. 
  • Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.
  • Price Action: ABBV shares traded lower by 1.16% at $142.39 on the last check Monday.
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Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsEurasiaEuropean Medicines Agency
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