Subcutaneous Entyvio for ulcerative colitis or Crohn's disease OKed by EC

Following a positive recommendation from the European Medicines Agency’s advisory committee in February, the European Commission has now granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

Marketed by Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502), Entyvio SC will be made available in both a pre-filled syringe and a pre-filled pen, the company said.

In its current intravenous formulation, Entyvio generated sales of 264 billion yen ($2.4 billion) in the first nine months of the current fiscal year, up almost a third on the same year-earlier period.