Takeda Receives Positive CHMP Opinion for Crohn Disease drug

Tokyo: Takeda Pharmaceutical Company Limited had announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). Takeda proposes to make vedolizumab SC available in both a pre-filled syringe and a pre-filled pen.

The CHMP opinion will now be reviewed by the European Commission. If approved, vedolizumab will become the maintenance therapy for UC or CD with both intravenous and subcutaneous formulations across the European Union, providing greater options for how patients receive their treatment.

"Today's positive CHMP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn's disease," said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. "Ulcerative colitis and Crohn's disease are life-long diseases, and it is important that patients have treatment options that suit their different preferences and lifestyles. We look forward to the European Commission's decision and the opportunity to bring a subcutaneous formulation of vedolizumab to these patients across Europe."

The positive opinion from the CHMP was based on the pivotal phase 3 VISIBLE trials which assessed the safety and efficacy of a SC formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active UC or CD who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.1,2,3 Data from a long-term, open-label extension study of patients from VISIBLE 1 and VISIBLE 2 was also considered.

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The VISIBLE clinical trial program aims to assess the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).

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