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Takeda's subcutaneous Entyvio approved in Europe for maintenance of moderate to severe Crohn's and ulcerative colitis

Published on 11/05/20 at 12:43pm

The European Commission has awarded marketing approval to Takeda’s subcutaneous formulation of its gut-selective biologic therapy Entyvio (vedolizumab) as a maintenance treatment of moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

The decision was backed up by Phase 3 data showing positive safety and efficacy in moderate-to-severely active UC or CD patients that achieved clinical response after week six weeks following two intravenous doses of open-label vedolizumab.

Takeda’s Adam Zaeske, Head of GI Franchise, Europe and Canada Business Unit, remarked: “We are delighted that the European Commission has approved the subcutaneous formulation of Entyvio. This allows physicians and adult patients to choose the delivery method that works best for each individual patient. Takeda’s commitment to treating gastrointestinal disease means that we are always looking to innovate to provide further therapeutic options to better meet the needs of the patients we serve.”

The subcutaneous formulation will be available in pre-filled syringe and pen forms, Takeda confirmed, and regulatory approval is also being pursued in other regions around the world.

Matt Fellows

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