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# FDA Approves Subcutaneous Entyvio After 46% vs. 14% Week-52 Remission in Ulcerative Colitis Trial
- URL: https://www.theamericanquorum.com/taq-historical-2023-09-30-healthcare/
- Published: 2023-10-01T03:59:00.000Z
- Updated: 2023-10-01T03:59:00.000Z
- Description: FDA approved subcutaneous vedolizumab for maintenance treatment of moderate-to-severe ulcerative colitis after VISIBLE 1 showed 46% remission at week 52 versus 14% with placebo.
- Author: Kenneth R. Deans Jr.
- Tags: Healthcare, #Import 2026-09-01 06:03

The Food and Drug Administration this week approved a subcutaneous formulation of Entyvio, or vedolizumab, for maintenance treatment of adults with moderately to severely active ulcerative colitis after initial intravenous therapy, giving patients the first U.S. biologic for the disease that can be continued either by infusion or by self-administered injection.

Takeda announced the [FDA approval on September 27](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/?ref=theamericanquorum.com). The company said the Entyvio Pen will deliver 108 mg of vedolizumab under the skin every two weeks after patients first respond to two intravenous induction doses. U.S. availability is expected by the end of October.

## VISIBLE 1 showed a large remission difference at one year

The approval rests on the Phase 3 VISIBLE 1 trial, which randomized patients who had responded after six weeks of intravenous vedolizumab induction to subcutaneous vedolizumab, continued intravenous treatment or placebo. In the group used for the U.S. subcutaneous approval comparison, 46% of patients receiving 108 mg under the skin every two weeks were in clinical remission at week 52, compared with 14% receiving placebo, a statistically significant difference.

The underlying [ClinicalTrials.gov record](https://clinicaltrials.gov/study/NCT02611830?ref=theamericanquorum.com) describes a multinational, randomized, double-blind study in adults with moderately to severely active ulcerative colitis. All participants first received open-label intravenous vedolizumab at weeks 0 and 2\. Responders at week 6 were then assigned to maintenance therapy, allowing investigators to test whether the subcutaneous formulation could sustain disease control over a year.

The pivotal results were published before approval in [Gastroenterology](https://pubmed.ncbi.nlm.nih.gov/31470005/?ref=theamericanquorum.com). Investigators led by William Sandborn reported that subcutaneous vedolizumab was effective as maintenance therapy after intravenous induction and provided an efficacy profile consistent with continued biologic treatment while introducing injection-site reactions as an expected route-specific adverse event.

## The new formulation changes how a long-established biologic can be delivered

Vedolizumab has been used intravenously in the United States for ulcerative colitis and Crohn’s disease since 2014\. It is a humanized monoclonal antibody that targets the alpha4beta7 integrin, interfering with migration of certain inflammatory white blood cells into gastrointestinal tissue. The mechanism is described as gut-selective because the targeted adhesion pathway is especially important in intestinal immune-cell trafficking.

The route of administration has practical consequences. Intravenous Entyvio requires scheduled infusions in a clinical setting. The newly approved pen allows an appropriate patient who has responded to intravenous induction to continue maintenance treatment with a subcutaneous dose every two weeks, potentially shifting part of long-term care from an infusion center to home.

Takeda had been pursuing that option for several years. In an [April 2023 regulatory update](https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-colitis/?ref=theamericanquorum.com), the company said FDA had accepted a resubmitted biologics license application after a 2019 complete response letter. Takeda said the earlier FDA concerns were unrelated to the VISIBLE 1 clinical efficacy and safety conclusions and that the resubmission included additional information requested by the agency.

## International experience preceded the U.S. decision

Subcutaneous vedolizumab is not a new concept globally. The European Commission [approved the formulation in 2020](https://www.takeda.com/newsroom/newsreleases/2020/european-commission-approves-subcutaneous-entyvio-for-use-as-maintenance-therapy-in-ulcerative-colitis-or-crohns-disease/?ref=theamericanquorum.com) for maintenance treatment in adults with ulcerative colitis or Crohn’s disease, giving clinicians abroad several years of experience with both syringe and pen delivery.

That European decision followed a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Takeda’s [February 2020 CHMP announcement](https://www.takeda.com/newsroom/newsreleases/2020/takeda-receives-positive-chmp-opinion-for-subcutaneous-vedolizumab-as-maintenance-therapy-in-uc-or-cd/?ref=theamericanquorum.com) said the recommendation was based on the VISIBLE Phase 3 program, including randomized studies in ulcerative colitis and Crohn’s disease and a long-term extension designed to assess continued safety and efficacy.

Longer follow-up also became available before the U.S. approval. Takeda reported [interim VISIBLE extension data](https://www.takeda.com/newsroom/newsreleases/2020/safety-and-efficacy-of-subcutaneous-entyvio-vedolizumab-sustained-during-long-term-maintenance-therapy-in-adults-with-moderately-to-severely-active-ulcerative-colitis/?ref=theamericanquorum.com) in October 2020 showing that adverse events remained consistent with the established safety profile and that clinical-remission rates were maintained among patients who continued subcutaneous therapy through longer treatment.

## Safety remains similar to intravenous treatment, with injection-site reactions added

The FDA-approved subcutaneous regimen does not eliminate the safety considerations already associated with vedolizumab. Patients can experience hypersensitivity reactions, infections and liver injury, and clinicians are advised to monitor for neurological symptoms that could raise concern for progressive multifocal leukoencephalopathy, although the drug’s gut-selective mechanism differentiates it from broader integrin blockade.

In the VISIBLE program, the overall safety profile of subcutaneous vedolizumab was generally consistent with intravenous therapy, with injection-site reactions becoming an additional expected adverse effect. Takeda’s approval announcement lists local redness, rash, swelling, bruising and hematoma among those reactions.

The Japanese component of the development program provides another independent clinical data set. A peer-reviewed [2020 study in Intestinal Research](https://pubmed.ncbi.nlm.nih.gov/32806876/?ref=theamericanquorum.com) evaluated subcutaneous vedolizumab in Japanese patients with moderately to severely active ulcerative colitis and found efficacy and safety findings broadly consistent with the global program.

## Choice of administration may become part of treatment planning

The approval does not make subcutaneous treatment interchangeable with initial therapy. Patients must first receive intravenous vedolizumab induction and demonstrate a clinical response before moving to the maintenance pen. Nor does the new route change the fundamental question of whether vedolizumab is the appropriate biologic for a particular patient compared with anti-TNF agents, interleukin-targeting therapies, small molecules or other treatment options.

What changes is the logistics of continuing an established therapy. Some patients may prefer the structure and clinical contact of infusion-center treatment, while others may value the ability to administer maintenance doses outside a facility. Health plans and health systems will also have to determine how pharmacy benefits, medical benefits, prior authorization and patient training differ between the two formulations.

The U.S. approval therefore represents a delivery innovation as much as a new treatment milestone. Vedolizumab’s mechanism and therapeutic role are already well established, but the option to move from intravenous induction to a self-administered maintenance pen gives adults with moderate-to-severe ulcerative colitis a materially different way to remain on the drug. With 46% of subcutaneous-treated VISIBLE 1 patients in remission at one year compared with 14% on placebo, FDA has now concluded that the alternative route provides sufficient evidence of efficacy and safety for U.S. use.