Subcutaneous Vedolizumab Approved for Moderate-to-Severe Crohn Disease


Announced on April 18, the approval is based on the VISIBLE 2 trial and comes less than 7 months after the approval of SC vedolizumab in ulcerative colitis.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved subcutaneous vedolizumab (Entyvio) for treatment of moderately to severely active Crohn disease, according to an announcement from Takeda Pharmaceuticals.

Announced on April 18, 2024, the approval is based on data from the VISIBLE 2 trial and indicates the agent for maintenance therapy in adults with moderately to severely active Crohn disease after induction therapy with intravenous vedolizumab.1

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine.1 “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”

The approval marks the third approval for vedolizumab and the second in the past 7 months, with the agent receiving an approval for moderate to severe UC. The September 2023 approval for subcutaneous vedolizumab was based on data from the VISIBLE 1 trial, which examined use of the agent among patients with moderate-to-severe ulcerative colitis, indicating use was associated with 46% of patients receiving subcutaneous vedolizumab 108 mg maintenance therapy achieving clinical remission at week 52 compared to 14% of patients receiving placebo (< .001).1,2

The VISIBLE 2 study, which served as the basis for the April 18, 2024, approval, was a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing the safety and efficacy of subcutaneous vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn Disease. For inclusion in the trial, participants were required to have who had a clinical response at week 6 following 2 doses of open-label vedolizumab intravenous therapy at weeks 0 and 2. Participants were also required to have had an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or TNF inhibitors.1

A total of 409 patients underwent randomization in a 2:1 ratio to subcutaneous vedolizumab 108 mg administered or placebo every 2 weeks. The primary outcome of interest for the trial was the proportion of patients achieving clinical remission at week 52, which investigators defined as a total Crohn’s Disease Activity Index (CDAI) score of less than 150.1

Upon analysis, results of the trial suggested a statistically significant proportion of patients receiving subcutaneous vedolizumab 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission relative to the placebo group (48% vs. 34%; P <.01) at week 52. Safety analyses of the trial indicated the observed safety profile was generally consistent with the known safety profile of intravenous vedolizumab, with the addition of injection site reactions.1

“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president and head of US Gastroenterology Business Unit at Takeda Pharmaceuticals.1


  1. Takeda Pharmaceuticals. U.S. FDA approves subcutaneous administration of Takeda’s ENTYVIO® (vedolizumab) for maintenance therapy in moderately to severely active crohn’s disease. Business Wire. April 18, 2024. Accessed April 22, 2024.
  2. Abigail Brooks. FDA approves subcutaneous vedolizumab for moderate to severe UC. HCP Live. September 28, 2023. Accessed April 22, 2024.
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