Takeda has announced that its subcutaneous (SC) Entyvio (vedolizumab) has been approved by the US Food and Drug Administration (FDA) as a maintenance therapy for adults with moderately to severely active Crohn’s disease (CD), following therapy with intravenous (IV) Entyvio.
The approval was based on results from the phase 3 VISIBLE 2 study.
Causing the digestive tract to become swollen and irritated, CD is a form of inflammatory bowel disease (IBD), which affects around ten million people worldwide, according to the European Federation of Crohn’s and Ulcerative Colitis Associations.
The randomised, double-blind, placebo-controlled trial assessed the safety and efficacy of SC Entyvio as a maintenance therapy in 409 adult patients with moderately to severely active CD who have experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators or tumour necrosis factor blockers.
Entyvio is a biologic therapy that is designed to specifically target the alpha4beta7 integrin to limit the ability of certain white blood cells to infiltrate tissues in the gut.
After injecting Entyvio SC or placebo every two weeks, 48% of patients receiving the maintenance therapy achieved long-term clinical remission compared to 34% of patients who received placebo.
Additionally, the safety profile of Entyvio SC was generally consistent with the safety profile of Entyvio IV.
Brandon Monk, senior vice president, head, US gastroenterology business unit, Takeda, commented: “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.”
Entyvio SC has already been approved in more than 50 countries, while Entyvio IV has been granted approval in over 70 countries, both including the US and EU.
Most recently, Entyvio SC was approved by the FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis, a form of IBD, which is available in the US as a single-dose prefilled pen.