‘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,’ said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. ‘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.’
Monday, April 1, 2019
Takeda Gets EMA Nod for Subcutaneous Ulcerative Colitis, Crohn’s Application
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (‘Takeda’) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for 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 pre-filled syringe and pen options.
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