How long has Entyvio been on the market?

Entyvio was launched in both the United States and European Union markets in June 2014. Entyvio, from Takeda Pharmaceuticals, was first approved by the U.S. Food and Drug Administration (FDA) on May 20, 2014. It is used for maintenance treatment of ulcerative colitis and Crohn's disease.

The U.S. approval timeline is as follows:

• In June 2013, Takeda Pharmaceuticals submitted a Biological License Application (BLA) to the FDA for the 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.

Learn More: Drug Approval History for Entyvio

What is Entyvio approved to treat?

Entyvio (vedolizumab) is a biologic therapy approved by the FDA to be used 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 2 and 6 weeks, then every eight weeks thereafter as a 30 minute IV infusion. Subcutaneous (SC) formulations, which are injected under the skin, are also approved in the U.S., Europe and Canada.

In the U.S, Entyvio subcutaneous formulation is approved for maintenance (long-term) treatment in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease after induction therapy with intravenous (IV) Entyvio. 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 healthcare provider'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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