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news.Japan-based Takeda Pharmaceutical Company (Takeda) and its wholly-owned subsidiary Takeda Pharmaceuticals USA have received approval from the US Food and Drug Administration (FDA) for a new biologic therapy, Entyvio (vedolizumab), to treat adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).
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At present, Entyvio is approved for inducing and maintaining clinical response and remission, improving endoscopic appearance of the mucosa.
The drug secured the approval to achieve corticosteroid-free remission in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.
Northwestern University Feinberg School of Medicine medical director Stephen Hanauer said 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.
"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," Hanauer said.
Takeda Pharmaceuticals USA president Douglas Cole said 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.
"Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders," Cole said.
The approved dose of Entyvio is 300mg which will be infused intravenously over 30 minutes at zero, two and six weeks, then every eight weeks thereafter.
The company said that patients should be observed during infusion and until the completion of the infusion.
In March 2014, the company had received a positive opinion for Entyvio to treat adults with moderately to severely active UC and CD from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Currently, Takeda is awaiting response from the European Commission on approval for Marketing Authorisation of Entyvio.
The Biologics License Application (BLA) submission was based on the largest Phase III clinical trial program conducted to date simultaneously evaluating both UC and CD patient populations in four clinical studies involving 2,700 patients in nearly 40 countries.
Three of these studies in the program were randomized, double-blind, placebo-controlled trials – GEMINI I (UC Trials I and II), GEMINI II (CD Trials I and III) and GEMINI III (CD Trial II).
These three trials evaluated adult patients with moderately to severely active UC or CD who had an inadequate response or intolerance to immunomodulator therapy; inadequate response, loss of response, or intolerance to a TNF blocker; or were corticosteroid dependent or had an inadequate response or intolerance to corticosteroids.
Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o