How long has Entyvio been on the market?

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Official answer

by Drugs.com

Entyvio was launched in both the U.S. and E.U. market in June 2014 and has been on the market for over 7 years in those countries. Entyvio, from Takeda Pharmaceuticals, was first approved by the U.S. Food and Drug Administration (FDA) on May 20, 2014. The U.S. approval timeline in the U.S. is as follows:

  • In June 2013, Takeda Pharmaceuticals submitted a Biological License Application to the FDA for approval of Entyvio.
  • It gained a priority review status from the FDA in September 2014 for the treatment of ulcerative colitis, and was fully approved for both ulcerative colitis and Crohn’s disease on May 20, 2014.
  • Entyvio is also approved in other countries, including Canada, China, and Japan for treatment of both ulcerative colitis and Crohn’s disease.

    • Entyvio (vedolizumab) is a biologic therapy used in adults for the treatment of Crohn's disease and ulcerative colitis. It is classified as an integrin receptor antagonist and works by preventing certain white blood cells from entering into your GI tract (intestine). This helps to control your inflammation (swelling) and symptoms.

    Entyvio is not to be used as first-line therapy, but is indicated when one or more standard therapies, such as corticosteroids, immunomodulators, or TNF blockers have not been adequate for treatment.

    After the first intravenous (IV) dose, it is given again at two and six weeks, then every eight weeks thereafter as a 30 minute IV infusion. Subcutaneous (SC) formulations, which are injected under the skin, are also now approved in the U.S., Europe and Canada.

  • In the U.S, Entyvio (vedolizumab) subcutaneous is approved for for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous (IV). Initial induction therapy with IV Entyvio is still required.
  • The subcutaneous form for UC use comes as a single-dose, prefilled pen or syringe. Patients or caregivers can injection Entyvio subcutaneously at home after training on the injection technique.

    • This is not all the information you need to know about Entyvio (vedolizumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

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