Entyvio Now Available in US – Press Release

ENTYVIO™ (vedolizumab) Now Available in the United States for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis and Crohn’s Disease

DEERFIELD, Ill., and OSAKA, Japan, June 16, 2014 /PRNewswire/ — Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced the United States (U.S.) commercial availability of a new biologic therapy, ENTYVIO™ (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

New medication from Takeda
Takeda Pharmaceuticals

“We understand how a great need still exists for additional treatment options for ulcerative colitis and Crohn’s disease patients,” said Nicole Mowad-Nassar, vice president, marketing, Takeda Pharmaceuticals, U.S.A., Inc. “We’re pleased that we were able to make Entyvio available for appropriate patients so quickly after receiving FDA approval.”

In May, the U.S. Food and Drug Administration (FDA) simultaneously approved Entyvio for the treatment of adults with moderately to severely active UC and CD. That same month, Entyvio was also granted Marketing Authorisation in the European Union from the European Commission (EC) for the treatment of adults with moderately to severely active UC and CD.

Entyvio is now available to U.S. healthcare providers 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 TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Entyvio is also indicated 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.

In order to connect patients in need with access and services for Entyvio, Takeda has launched EntyvioConnect, with dedicated case managers available to answer questions. For more information, visit www.ENTYVIO.com/hub/ .

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