Skip to content
My WebMD Sign In, Sign Up

Ulcerative Colitis Health Center

Font Size

Entyvio Approved for Ulcerative Colitis and Crohn's Disease

Two chronic gastrointestinal diseases

WebMD News from HealthDay

By Scott Roberts

HealthDay Reporter

TUESDAY, May 20, 2014 (HealthDay News) -- Entyvio (vedolizumab) has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe forms of two gastrointestinal conditions -- ulcerative colitis and Crohn's disease.

The approval applies to people for whom standard therapies -- such as corticosteroids or tumor necrosis factor-blocking medications -- have failed.

Ulcerative colitis, affecting about 620,000 Americans, causes inflammation and ulcers in the large intestine. This can lead to abdominal discomfort, bleeding and diarrhea, the FDA said in a news release.

Crohn's causes inflammation and irritation of any part of the gastrointestinal tract. More than 500,000 Americans have been diagnosed with Crohn's, the FDA said.

The most common side effects of Entyvio include headache, joint pain, nausea and fever. More serious adverse reactions observed during clinical testing included serious infection and allergy-like (hypersensitivity) reaction.

Though no clinical trial participants contracted a rare, often-fatal nervous system infection called progressive multifocal leukoencephalopathy (PML), the FDA said Entyvio users should be monitored for neurological signs of PML.

Entyvio is marketed by Takeda Pharmaceuticals America, based in Deerfield, Ill.

Today on WebMD

basket of vegetables
Article
IBD Overview Slideshow
Slideshow
 
Ulcerative Colitis Managing Flares
Slideshow
what is ibs
Article
 

Supplements UC
Video
Ulcerative Colitis Health Check
Tool
 
Ulcerative Colitis Diet
Slideshow
Ulcerative Colitis Diet Yogurt
Article
 

Ulcerative Colitis Surgery
Slideshow
Ulcerative Colitis Medications
Article
 
Exercising When You Have A GI Disorder
Article
Picture Of The Intestines
Image Collection
 

WebMD Special Sections