FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease


Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

Stomach ache concept. Hands holding belly abdomen suffering from indigestion, gastrointestinal disease, pain, inflammation. Image Credit: Adobe Stock Images/valiantsin

Image Credit: Adobe Stock Images/valiantsin

The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy.

The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2

“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 assistant professor of medicine, TCU School of Medicine, in a press release. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”

In September, the FDA also approved an SC form of Entyvio as a maintenance therapy for moderately to severely active ulcerative colitis. In this indication, the approval was based on data from the Phase III VISIBLE 1 study, which employed a method similar to the VISIBLE 2 study. After 52 weeks, 46% of patients achieved clinical remission with the treatment of Entyvio.3

“With the FDA approval of subcutaneous Entyvio, patients and physicians who want Entyvio’s clinical profile along with flexibility of administration now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis,” said Brandon Monk, SVP, head, US gastroenterology business unit, Takeda, in a press release. “Takeda is committed to meeting the varied medical needs, circumstances and personal preferences of people living with UC as they progress in their lifelong journey with the disease. Entyvio is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”

According to the Centers for Disease Control and Prevention (CDC), around 1.3 million people in the United States were diagnosed with inflammatory bowel diseases in 2015, such as Crohn’s disease and ulcerative colitis.4

“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 Monk, in the press release. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”


1. U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease. Takeda. April 18, 2024. Accessed April 19, 2024. https://www.takeda.com/newsroom/newsreleases/2024/fda-approves-subcutaneous-administration-of-entyvio/

2. FDA Approves Takeda's Entyvio™ (vedolizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease. Takeda. May 21, 2014. Accessed April 19, 2024. https://www.takeda.com/newsroom/newsreleases/2014/FDA-Approves-Takedas-Entyvio-vedolizumab-for-the-Treatment-of-Adults/

3. U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis. Takeda. September 27, 2023. Accessed April 19, 2024. https://www.takeda.com/newsroom/newsreleases/2023/US-FDA-Approves-Subcutaneous-Administration-of-Takeda-ENTYVIO-vedolizumab-for-Maintenance-Therapy-in-Moderately-to-Severely-Active-Ulcerative-Colitis/

4. People with IBD Have More Chronic Diseases. CDC. Accessed April 19, 2024. https://www.cdc.gov/ibd/features/IBD-more-chronic-diseases.html

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