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Takeda’s vedolizumab receives US FDA approval to treat moderately to severely active Crohn’s disease

Osaka, Japan
Saturday, April 20, 2024, 16:00 Hrs  [IST]

Takeda announced that the US FDA has approved Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio.  The subcutaneous administration of Entyvio was also approved by US FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the US as a single-dose prefilled pen (Entyvio Pen).

The approval is based on the VISIBLE 2 study (SC CD trial), a phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of Entyvio as maintenance therapy in adult patients with moderately to severely active CD who had clinical response at Week 6 following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2. The primary endpoint was clinical remission at week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of =150.

“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. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of Entyvio, regardless of route of administration.”

In VISIBLE 2, a total of 409 patients were randomized at week 6 in a double-blind fashion (2:1) to Entyvio 108 mg administered by SC injection or placebo every 2 weeks. Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders).

A statistically significant proportion of patients receiving Entyvio SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical studies, the Entyvio SC safety profile was generally consistent with the known safety profile of Entyvio IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for Entyvio SC. The most common adverse reactions reported with Entyvio IV (incidence =3% and =1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

“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, head, US Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

Vedolizumab is a biologic therapy and is approved for intravenous (IV) and subcutaneous (SC) administration (approvals vary by market). Vedolizumab SC has been granted marketing authorization in the United States, European Union and more than 50 countries. Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union. Globally, vedolizumab IV and SC have more than one million patient years of exposure to date.3 Vedolizumab is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).4 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn’s disease. By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

 




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