Takeda's Vedolizumab Secures US FDA Nod To Treat Crohn's Disease

Takeda, a leading pharmaceutical firm, declared that the US Food and Drug Administration (FDA) has granted approval for the subcutaneous administration of Entyvio (vedolizumab) as maintenance therapy in adults with moderately to severely active Crohn's disease (CD) after initiating treatment with intravenous (IV) Entyvio. In September 2023, the US Food and Drug Administration (FDA) approved the subcutaneous administration of Entyvio for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and the single-dose prefilled pen known as Entyvio Pen is currently available in the United States.

The VISIBLE 2 study (SC CD trial), a phase 3 randomized, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of an SC formulation of Entyvio as maintenance therapy in adult patients with moderately to severely active CD who had a clinical response at Week 6 following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2. A total Crohn's Disease Activity Index (CDAI) score of 150 was used as the primary endpoint, 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, 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.”