Takeda Receives FDA Approval For Ulcerative Colitis Therapy

(RTTNews) - Takeda (TAK) said that the U.S. Food and Drug Administration has approved a subcutaneous or SC administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis or UC after induction therapy with Entyvio intravenous (IV).

The company noted that Entyvio is the only FDA-Approved Ulcerative Colitis Biologic that offers the choice of Intravenous or Subcutaneous maintenance therapy.

The company expects that Entyvio SC will be available in the U.S. as a single-dose pre-filled pen (ENTYVIO Pen) by the end of October.

Takeda said it does not expect a material impact on the full year consolidated reported forecast for the year ending March 31, 2024, as a result of this approval.

Additionally, a Biologics License Application for an investigational SC administration of Entyvio for the treatment of adults with moderately to severely active Crohn's disease is currently under review by the FDA.

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