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EMA accepts marketing authorization application of subcutaneous Entyvio for IBD
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The European Medicines Agency has accepted a marketing authorization line extension application for a subcutaneous formulation of Entyvio for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease, according to a company press release.
“This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,” Adam Zaeske, head, GI Franchise, Europe and Canada Business Unit, Takeda, said in the release. “If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle.”
The proposal is to make vedolizumab (Entyvio, Takeda) available in both pre-filled syringe and pen options, according to the release.
The application, according to the release, is based on the positive results of the phase 3 VISIBLE 1 trial that was presented at UEG Week 2018.