FDA accepts Takeda's BLA for subcutaneous Entyvio

The US Food and Drug Administration has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC).

The drug’s maker, Takeda (TYO: 4502), whose shares were up nearly 4% at 4,291 yen today, proposes to make vedolizumab SC available in both pre-filled syringe and pen options.

Vedolizumab is set to be the only maintenance therapy to offer the option of both intravenous or subcutaneous formulations for patients with ulcerative colitis, Takeda noted. The subcutaneous formulation is currently under review by the European Medicine Agency.