CHMP Backs Vedolizumab for Ulcerative Colitis, Crohn's

Megan Brooks

March 21, 2014

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of vedolizumab (Entyvio, Takeda Pharmaceuticals) for adults with moderate to severe ulcerative colitis or Crohn's disease who fail to respond to or cannot tolerate steroids, suppressants, or tumor necrosis factor–α (TNF-α) antagonists.

Vedolizumab was developed to address the 'unmet medical need' recognized in moderately to severely active ulcerative colitis and Crohn's disease patients, the EMA said in a statement.

Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody that binds exclusively to the α4β7 integrin, a key mediator of gastrointestinal inflammation.

"This novel mechanism of action allows for a more selective, intestinal-targeted anti-inflammatory activity and it may offer a significant additional treatment option for the management of ulcerative colitis and Crohn's disease patients who have failed standard available therapies," the EMA said.

Vedolizumab was recommended for approval at an advisory committee meeting of the US Food and Drug Administration held December 9, 2013, as reported by Medscape Medical News.

The efficacy of vedolizumab was demonstrated in randomized, double-blind, placebo-controlled trials published in August 2013 in the New England Journal of Medicine.

Ulcerative colitis and Crohn's disease are the 2 most common types of inflammatory bowel disease, affecting more than 2 million people across the European Union.

The CHMP opinion on vedolizumab will now be forwarded to the European Commission, which will make a final decision.


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