04:13 AM EDT, 04/19/2024 (MT Newswires) -- Takeda Pharmaceutical ( TAK ) said Thursday it received US Food and Drug Administration approval for subcutaneous injection of Entyvio as a maintenance therapy in adults with moderately to severely active Crohn's disease following induction therapy with intravenous Entyvio.

The approval followed a 409-patient phase 3 trial of Entyvio in which 48% of patients met the primary endpoint of clinical remission at 52 weeks vs 34% who received a placebo.

The FDA last year approved subcutaneous injection of Entyvio, also known as vedolizumab, as a maintenance treatment in adults with moderately to severely active ulcerative colitis. The drug is already available in the US as a single-dose, prefilled pen.

Shares of the Japanese pharmaceutical company were up more than 2.5% in Thursday's after-hours activity.