Panel Recommends European Approval of Entyvio At-Home Injection

Panel Recommends European Approval of Entyvio At-Home Injection
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of a subcutaneous (under-the-skin) injection of Entyvio (Vedolizumab), the gut-selective maintenance therapy for adults with moderately to severely active Crohn’s disease and ulcerative colitis. The recommendation brings Takeda Pharmaceuticals' new SC formulation of Entyvio one step closer to becoming the only self-administered maintenance therapy that can be given at home instead of at the hospital.  The company plans to make Entyvio SC available in both a pre-filled pen and a pre-filled syringe. “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 of Takeda's GI franchise for Europe and Canada, in a press release. “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,” Zaeske said. CHMP’s recommendation comes on the heels of positive Phase 3 data presented at the 15th Congress of the European Crohn’s and Colitis Organisation in Austria. The Phase 3 VISIBLE 2 clinical trial (NCT02611817) assessed the safety and efficacy of the SC formulation of Entyvio as maintenance therapy.  Results showed that 48% of participants with moderately to severely active CD, who responded to two doses of intravenous (IV) (into-the-vein) Entyvio treatment after six weeks and were then assigned 108 mg of SC maintenance Entyvio ever
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