FDA Approves Vedolizumab for Maintenance Therapy to Treat Crohn Disease


The primary endpoint of the study was clinical remission at week 52 with vedolizumab

The FDA recently announced the approval of vedolizumab (Entyvio, Takeda) subcutaneous (SC) for maintenance therapy, to treat moderate to severe active Crohn disease (CD) following induction therapy with intravenous (IV) vedolizumab. Prior to the recent approval, vedolizumab was FDA approved in September 2023 for maintenance treatment for individuals with moderate to severe active ulcerative colitis (UC), according to study authors.

“The approval of subcutaneous Entyvio in [CD] delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or [CD], 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 United States Gastroenterology Business Unit at Takeda, in a press release. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

UC and CD are connected as the 2 most common forms of inflammatory bowel disease (IBD), that occur as chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal (GI) tract, according to study authors. However, the specific cause of both conditions is unknown, leading to conclusions like environmental factors, genetics, and intestinal microbiota. UC transpires in the large intestine as CD can impact any portion of the GI tract from the mouth to the anus. Other differences include CD impacting the thickness of the bowel wall, as UC only implicates the innermost lining of the large intestine.

The study authors noted that individuals with UC can expect symptoms of abdominal discomfort, or loose bowel movements that could contain blood. Following, individuals with UC can expect symptoms of abdominal pain, diarrhea, and weight loss.

Vedolizumab could aid individuals with CD, as a biologic therapy and a humanized monoclonal antibody. The study authors noted that it has been previously approved for IV and SC administration and both have been granted approvals in the United States, European Union, and additional countries. Following, vedolizumab is intended to “antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1),” according to the study authors. The alpha4beta7 integrin is conveyed by circulating white blood cells, which have a connection in mediating the inflammatory process in UC and CD.

The approval was based on the phase 3 randomized, double-blind, placebo-controlled trial, VISIBLE 2 Study (SC CD Trial) that evaluated the safety and efficacy of a SC formulation of vedolizumab as a maintenance therapy to treat moderate to severe CD. The study included 409 individuals that needed to have a clinical response at week 6 after 2 doses of vedolizumab IV at weeks 0 and 2, according to study authors.

At week 6 of the study, the 409 individuals were randomly assigned to receive 108 mg of vedolizumab, SC injection, or a placebo every 2 weeks. The study authors noted that the primary endpoint of the study was clinical remission at week 52.

“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 of the Department of Research and Education for the GI Alliance Research and assistant professor of medicine at the 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.”

The most reported adverse events with vedolizumab IV included headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities. However, the safety profile of vedolizumab SC was consistent with vedolizumab IV, according to study authors.

U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease. Business Wire, News release. April 18, 2024. Accessed April 19, 2024. https://www.businesswire.com/news/home/20240401246883/en.

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