Takeda's Entyvio approved to treat moderately to severely active ulcerative colitis and Crohn's disease

DEERFIELD, Ill. — Takeda Pharmaceutical on Tuesday announced that the Food and Drug Administration simultaneously approved a new biologic therapy, Entyvio (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.

"Patients with moderately to severely active ulcerative colitis or Crohn's disease, and the healthcare professionals who care for them, need additional new treatment options," said Douglas Cole, president of Takeda Pharmaceuticals U.S.A. "Entyvio reflects an expansion of Takeda's commitment to supporting patients with gastrointestinal disorders."

"Entyvio is a new option that works to block important contributors to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn's disease," stated Stephen  Hanauer, medical director at the Digestive Health Center at Northwestern University Feinberg School of Medicine. "The clinical trial program evaluated the efficacy and safety profile of Entyvio and demonstrated that Entyvio has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease."

Entyvio is approved for inducing and maintaining clinical response and remission, improving endoscopic appearance of the mucosa and achieving corticosteroid-free remission in adult patients with moderately to severely active UC who have 1) had an inadequate response with, lost response to or were intolerant to a tumor necrosis factor blocker or immunomodulator or 2) had an inadequate response with, were intolerant to or demonstrated dependence on corticosteroids. 

Entyvio also is approved for achieving clinical response and remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active CD who 1) have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator or 2) had an inadequate response with, were intolerant to or demonstrated dependence on corticosteroids.

The Entyvio dose regimen is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.