Takeda’s Entyvio gets US FDA approval to treat ulcerative colitis & Crohn’s disease

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The United States Food and Drug Administration (US FDA) simultaneously approved Takeda Pharmaceutical’s new biologic therapy Entyvio (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).

“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,” said Stephen B. Hanauer, managing director, medical director, Digestive Health Center, Northwestern University Feinberg School of Medicine. “The clinical trial programme 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 now 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 had an inadequate response with, lost response to, or were intolerant to a tumour necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Entyvio is also approved for achieving clinical response and remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.

“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, Takeda Pharmaceuticals USA, “Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders.”

The Entyvio dose regimen is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter. Patients should be observed during infusion and until the infusion is complete. See dosage and administration section in full prescribing information.

In March, Entyvio received a positive Opinion for the treatment of 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), and Takeda is awaiting response from the European Commission on approval for Marketing Authorisation.

The Biologics License Application filing with the FDA was supported by the largest Phase 3 clinical trial programme 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 were randomised, 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). GEMINI I, II and III 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.

Adverse reactions were reported in 52 per cent of patients treated with Entyvio and 45 per cent of patients treated with placebo (UC Trials I and II: 49 per cent with Entyvio and 37 per cent with placebo; CD Trials I and III: 55 per cent with Entyvio and 47 per cent with placebo). Serious adverse reactions were reported in 7 per cent of patients treated with Entyvio compared to 4 per cent of patients treated with placebo (UC Trials I and II: 8 per cent with Entyvio and 7 per cent with placebo; CD Trials I and III: 12 per cent with Entyvio and 9 per cent with placebo).

The most common adverse reactions reported with Entyvio (incidence greater than or equal to 3 per cent and greater than or equal to 1 per cent 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.

Source: PharmaBiz

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