(RTTNews) – Takeda Pharmaceutical company Limited said that the European Commission has granted a Marketing Authorization for the subcutaneous formulation of Entyvio, a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen.
“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,” said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda.
ulcerative colitis and Crohn’s disease are two of the most common forms of inflammatory bowel disease (IBD) and affect more than two million people in Europe. The decision by the European Commission means that EntyvioSC is now approved for use in the 27 member states of the European Union, plus the United Kingdom, Norway, Liechtenstein and Iceland.
In addition to having received approval from the European Commission, Entyvio SC has been submitted for regulatory review with other regulatory authorities worldwide.
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